animal health buyer’s guide...amatsi group 28 farma research animal health ashish life science 29...

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Animal Health Buyer’s Guide

IHS Markit Animal Health 2

Consultancy 3

Klifovet AG 3 ERAvet 3 Kynetec 4 Cebiphar 5 Veterinary Insights 6 Amatsi Group 6 Veterinary Research Management 7 Cyton Biosciences 8 Triveritas 8 Produkt + Markt 9 Vetspin 9 Ondax Scientific 9

CRO’s 11

Klifovet AG 11 Cebiphar 11 Clinvet 13 ERAvet 14 Löhlein & Wolf Vet Research 14 BioMedVet Research 15 IDEXX BioAnalytics 15 Moredun Scientific 16 Amatsi Group 17 Veterinary Research Management 17 Triveritas 18 Farma Research Animal Health 18 Vetspin 19 Ondax Scientific 19

Education & Training 21

Klifovet AG 21 Veterinary Research Management 21 Cyton Biosciences 22 Triveritas 23

IT Services 24

Klifovet AG 24 Kynetec 24 Triveritas 25 Ondax Scientific 25

Manufacturer 27

Klifovet AG 27 Nordson 28 Amatsi Group 28 Ashish Life Science 29 Dechra 30 Triveritas 31

Market Research 32

Klifovet AG 32 Kynetec 32 Veterinary Insights 33 Triveritas 34 Ondax Scientific 34

Marketing Sales 36

Klifovet AG 36 Veterinary Insights 36 Triveritas 37

Produkt + Markt 38

Recruitment 39

Klifovet AG 39 VET Recruiter 39 De Causmaecker & Associates 40 Triveritas 41

Regulatory 42

Klifovet AG 42 ERAvet 42 Amatsi Group 43 Cyton Biosciences 44 Triveritas 45 Estendart 45 Farma Research Animal Health 45 Ondax Scientific 46

IHS Markit Animal Health Buyer’s Guide: Introduction


IHS Markit Animal Health

At IHS Markit, we offer market-leading animal health information solutions

powered by our globally recognised brand Animal Pharm. Our specialist team of

experts offer comprehensive news and independent analysis across the global

industry, with market reporting solutions to support your organisation and ensure

you develop the best response in an ever-changing environment.

These services are part of IHS Markit’s agribusiness industry solutions, with a

suite of services offering an unparalleled depth of understanding and expertise

over a multitude of complex markets. To learn more about our capabilities across

the agribusiness value chain, click here.

To advertise in this guide please contact Ben Watkins:

Tel: +44 (0)7833 047 163

Email: [email protected]

https://agribusiness.ihsmarkit.com/index.html

mailto:[email protected]


IHS Markit Animal Health Buyer’s Guide: Consultancy


Consultancy

Klifovet AG

Klifovet AG

Located in the center of Europe, thinking globally: Klifovet AG is a Munich/ Germany-based veterinary CRO providing the animal health and animal nutrition industry with services covering all aspects of product development of veterinary medicinal products and feed additives:

• Strategic consultancy: partner search and project management for the complete product development phase: from the idea to the market.

• SME, MUMS, scientific advice: we assure that you enjoy all justified benefits.

• Regulatory consultancy: analyses and strategy, expert reports, negotiations with the authorities, dossier writing, electronic submissions.

• Pharmacovigilance services incl. QPPV and life cycle management.

• Studies: Planning and conduct of EU GLP/GCP-compliant veterinary safety and efficacy studies in all target animal species.

• QA and QM: Quality assurance and management including audits to GCP, GLP and GMP.

• Data entry, data management and statistics. • Electronic Data Capture: STUDYBASE®, the validated

study management software exclusively made for animal studies.

• Import and manufacturing of veterinary medicinal products and clinical study supplies to GMP: re-packaging, labelling, storage, EU QP release.

• EU representation as Qualified Person for GMP (QP) and Qualified Person for Pharmacovigilance (QPPV).

• Seminars and trainings.

KLIFOVET is certified to ISO 9001, holds EU-GMP accreditation and fully complies with VICH GCP. KLIFOVET won the prestigious Animal Pharm Award twice in 2006 (Best Supporting Role) and 2016 (Best CRO), showing our long-term excellent performance for our clients.

Klifovet AG Geyerspergerstr. 27 D-80689 München Germany Tel: +49-89-5800820 Fax: +49-89-58008215

Contact: Dr. Klaus Hellmann www.klifovet.com

ERAvet

ERAvet

Founded in 2011, ERAvet has established itself as one of the leading Animal Health consultancies in Germany. We now serve 35 % of the active animal health companies in our domestic market including global corporations as well as small and medium-sized enterprises.

http://www.klifovet.com/




ERAvet

ERAvet Neue Straße 23 26316 Varel Germany Tel: +49 (0)4451 / 9182040

Contact: Dr. Michael Lammers, M.D.R.A. [email protected] www.eravet.eu

Regulatory strategy, regulatory project management and the safety part of the dossier are our core in-house competencies and our company’s growing reputation has increasingly earned us opportunities to participate in a wide range of challenging projects across Europe. So far, ERAvet has managed and contributed to more than 25 successful application procedures resulting in nearly 300 marketing authorisations.

ERAvet offers full pharmacovigilance services including QPPV responsibility and establishment/ maintenance of pharmacovigilance systems according to European standards. We have processed thousands of cases and have expertise in small and medium-sized pharmacovigilance systems as well as global pharmacovigilance processes.

We keep our organisation slim, ensuring efficient processes and competitive rates. Our very committed in-house staff works closely with you while our dedicated network of professionals provides all the required additional scientific disciplines and services. You get a single-source solution from a highly efficient team put together especially for your project.

If you are seeking regulatory intelligence or highly experienced additional capacities, ERAvet is the partner you are looking for.

Kynetec

Kynetec

As the leading research specialist in animal health, Kynetec helps companies around the world understand the dynamics of their industry, from livestock producers to pet owners, veterinarians, the sales channel or the food chain. We turn research into business opportunities and enable clients to create winning strategies.

We have expertise in all the major categories needed for keeping livestock operations running smoothly, combined with sector knowledge covering companion animals, production animals and aquaculture. We conduct tracking studies for monitoring market trends, customized research for answering unique business challenges and provide market forecasts to support the long-term vision.

Everything we do is delivered by a team of specialists who understand the challenges impacting the animal health industry. Our coverage extends to major and niche sectors of our industry, where we regularly undertake research projects in more than 70 countries. With our international team of experts located around the world, no matter where you are, we can help.

Kynetec 1807 Park 270 Drive Suite 300 St. Louis Missouri 63146 USA Tel: +1 314 878 7707

Contact: Keri McBride [email protected] www.kynetec.com


http://www.eravet.eu/


http://www.kynetec.com/




Cebiphar

Cebiphar

Do you need to develop and ensure Life Cycle management of your veterinary drugs, biological, zootechnical & food products?

CEBIPHAR is your trusted partner for:

Multi-site clinical trials for farm & companion animals (according to GCP principles): efficacy, safety, palatability, microbiological studies.

On site experimental studies:

TAS, PK, residues, Minimum Inhibitory Concentrations (MIC), Minimum Bactericidal Concentrations (MBC) etc.

Animal models: Large portfolio of models encompassing the major diseases of livestock (lactating cow, cattle, pre-ruminant calves, sheep, swine, poultry, rabbit...) allowing the evaluation of a variety of products (vaccines, antibiotics, NSAIDs, etc.)

Five reasons you can entrust your projects to CEBIPHAR:

1. People: Experienced staff dedicated to your project.

2. Expertise: Over 37 years of experience and more than 800 studies performed.

3. Comprehensive services: - Strategic advice & project management, for both preclinical & clinical studies. - Regulatory consultancy: audit of dossier, regulatory support, writing of parts III & IV. - Laboratory services: analytical development, VICH stability studies, QC, microbiology (microbiological assay of antibiotics, MIC, MBC, collection of field strains).

4. Animal facilities: - On-site experimental facility adapted to multiple animal species. - Partnership with INRA (French National Institute for Agricultural Research) for confinement studies.

5. Rigorous quality system & GLP-GMP accredited environment.

Contacts: Olivier Roy, Director of Veterinary Preclinical & Clinical Department: [email protected] Stéphanie Burger-Prin, Marketing & Commercial Director: [email protected]

Member of the Teranga group Cebiphar 1 rue de la Bodinière 37230 Fondettes France Tel: +33 (0)2 47 42 48 48

Contact: Oliver Roy [email protected] www.cebiphar.com




http://www.cebiphar.com/




Veterinary Insights

Veterinary Insights

Established for over 20 years and a division of the Insights DBM business, Veterinary Insights offers a range of veterinary business information services, all with the single aim of transforming data into actionable insight.

From bespoke CRM systems to data driven business intelligence, competitor activity and benchmarking analysis, rebates to specialist web projects, we provide best-in-class commercial insights across the animal health industry.

Working with the UK’s leading health care companies, Veterinary Insights have built the largest UK animal health database of veterinary transactions and activities worth over £100 million, involving over 300 vet practices, 900,000 cats, dogs and other companion animals.

We deliver proven results by truly understanding and transforming our customers’ data needs. Our business intelligence provides unparalleled commercial insight in many innovative ways. For more information, do contact us on the details below.

Contacts: Alexander Arpino, Managing Director: [email protected] Emma Whyman, Marketing Manager: [email protected]

Veterinary Insights Unit 5 The Old Stables Hoadlands Farm London Road Handcross RH17 6HB Tel: 01403 800 135

Contact: Alexander Arpino Alexander.arpino@ veterinaryinsights.com www.veterinaryinsights.com

Amatsi Group

Amatsi Group

Amatsi Group is a leading Early CDMO (Contract Development and Manufacturing Organization) with over 15 years of experience in veterinary product development.

WE PROVIDE:

• BIOSERVICES (In life studies and Bioanalysis): PK and ADME studies, Safety studies (residues, TAS), some efficacy models.

• PHARMACEUTICAL ANALYSIS SOLUTIONS (Development & validation of analytical methods, VICH stability studies, Contract cGMP QC).

• FORMULATION DEVELOPMENT & MANUFACTURING (small-batch-focused).

• CLINICAL TRIAL SUPPLIES (Packaging, GMP storage, QP release, experience with distribution of IVPs to clinical sites).

• Under GLP and GMP environment (EMA, FDA compliance).

OUR KEY ASSETS:

Amatsi Group EU: Parc de Genibrat 31470 Fontenilles, France Tel: + 33 (0)5 6214 7184

USA: 2458 N. Chamberlain St., Terre Haute, IN 47805 Tel: +1 812 877 1009

[email protected] http://www.amatsigroup.com





http://www.veterinaryinsights.com/


http://http/www.amatsigroup.com




Amatsi Group

• Facilities for farm and companion animals both in the US and in France (total 7 400 m2/80,000sq ft).

• Experience working with over 80 marketed veterinary products.

• AAALAC accreditation • 6 D.V.M. on site • In life & bioanalytical capacities at the same site

in France. • Option for full project management supported by our

CMC-RA team. • Mastering both US & EU veterinary guidelines.

OUR ADDED VALUES:

• Optimization of development timelines by managing project continuum.

• Maximization of regulatory validation by providing reliable data and thorough reports.

Veterinary Research Management

Veterinary Research Management Ltd.

Specialists in research management with proven expertise in project delivery. Our services include:

• Project management • Registration expertise - NCE’s & generics • Dose optimization • GLP/GCPv compliant test facilities • Dose determination, dose confirmation, safety, efficacy,

residues, bioequivalence & pK studies in livestock & companion animals.

• Specialist parasitology expertise & parasite supply Multi-country field studies.

• In vitro studies • Scientific writing - peer reviewed publication, editorials,

expert statements, study reports & regulatory defence.

VRM also represents Ridgeway Research Ltd (UK), Invetus Pty Ltd (Australia), Northwest Biopharm Ltd (Ireland), Vetspin S.r.l (Italy) and Cyton Biosciences (UK). Affiliations with these other organisations provide VRM with direct access to first-class test facilities across the world and an expert team of interdisciplinary scientists, to draw on as appropriate to deliver your project.

Veterinary Research Management Ltd. The Mews Studio, Portland Road, Malvern, Worcs. WR14 2TA UK

Tel: +44 1684 568998 or +44 7968 696683

[email protected] www.vrm.uk.com


http://www.vrm.uk.com/




Cyton Biosciences

Cyton Biosciences Ltd.

Expertise in depth

Cyton is a full-service animal health consultancy providing specialist multi-disciplinary technical expertise in quality, safety and efficacy, as well as regulatory affairs for the following product types:

• Pharmaceuticals • Immunologicals • Novel therapies • Feed additives

Our clients include 8 of the top 10 global animal health companies and we have an equally broad base of SME clients and start-up companies, giving us a wealth of varied experience and an appreciation of every client's uniqueness.

Our team: Cyton's veterinarians, chemists, toxicologists and regulatory experts work with a wide range of global contract research organisations and contract manufacturers, ensuring that product development projects can be delivered to match our clients' specific needs.

Global support: We understand the importance of local expertise, and through working closely with our sister companies and trusted partners, we can fulfil our customers' needs and achieve their product registrations in their target markets.

Contact us: Cyton has the technical and regulatory expertise to negotiate any challenges during product development and registration. Please get in touch for a free initial consultation.

Cyton Biosciences Ltd. 68 Macrae Road Eden Office Park Bristol BS20 0DD UK

Cyton AH Biosciences GmbH Konrad-Zuse-Ring 25 68163 Mannheim Germany

[email protected] www.cyton.com Twitter.com/CytonBio LinkedIn.com/company/Cyton-Biosciences

Triveritas

Triveritas

A global CRO offering state of the art technological data management resources in AH clinical studies. Triveritas Electronic Data Capture System, from Prelude Dynamics, is a web-based EDC system compliant with 21 CFR 11. From the input to the output of data, our comprehensive data collection form library offers adaptable solutions for specific study requirements and designs.

Our flexible approach uses innovative strategies to address timelines and budget.

Expertise includes: Full Product Development; VICH GCP Clinical Studies; Regulatory Affairs; Strategic Advice; Quality Assurance (GxP); Training; Project Management and Pharmacovigilance.

Triveritas Head Office: Bank Barn, How Mill, Brampton Cumbria CA8 9JY UK Tel: +44 (0) 845 123 2888

[email protected] www.triveritas.com


http://www.cyton.com/

http://twitter.com/CytonBio

http://linkedin.com/company/Cyton-Biosciences/



http://www.triveritas.com/




Produkt + Markt

Produkt + Markt

Deep understanding of markets and customers – that's what we stand for since 1970. PRODUKT + MARKT has extensive experience in animal health and agribusiness marketing research.

With our interdisciplinary team we provide outstanding expertise for the lifestock and companion animal markets of the world. Reliable – actionable – cost effective.

Give us a call to explore the opportunities.

Produkt + Markt Otto-Lilienthal-Str. 15 D-49134 Wallenhorst Germany Tel: 00 49-5407-885-212

Contact: Karl-Georg Herbert [email protected] www.pundm.de

Vetspin

Vetspin Srl

Vetspin is a GLP and GCP accredited CRO specialised in studies of safety and efficacy on farm animals, including cattle, pig, sheep, poultry (chicken, turkey, duck, guinea fowl) and rabbit.

• Target animal safety, pharmacokinetic, residue depletion, dose determination on infected animals.

• Development and validation of analytical methods for veterinary drugs on plasma, tissues (liver, kidney, fat, fat+skin, muscle, other tissues), milk, eggs, manure.

• Data analysis (Biostatistics). • Regulatory affairs: Dossiers, Expert Reports.

Vetspin S.r.l. Via Tolara di Sopra 5040064 Ozzano dell' Emilia (BO) Italy Tel: +39 (0)51 2097500

[email protected] www.vetspin.com

Ondax Scientific

Ondax Scientific SL

The European Specialists in Clinical Trials

Local Expertise with a Global Approach

ONDAX Scientific is an independent Contract Research Organisation (CRO) specialised in providing Europe-wide Clinical Trial Services to the animal health industry. Our Clinical Trial Services include test permit applications, study set-up, trial monitoring, auditing, data entry, data analysis and study report writing both in companion animals and livestock. We are highly experienced conducting a wide range of field

Ondax Scientific SL Aptdo. 336 20280 Hondarribia Gipuzkoa


http://www.pundm.de/


http://www.vetspin.com/




Ondax Scientific SL

Spain Tel: +34 943 646 087 Fax: +34 943 646 158

Contact: Patxi Sarasola [email protected] www.ondax-scientific.com/

studies to evaluate the efficacy and safety of Pharmaceuticals and Biologicals both at national and multinational level in several therapeutic areas. We operate in a highly responsive, flexible manner to suit Sponsor requirements meeting targets in a timely and cost-effective manner.

Our Services include:

Clinical Trials:

• VICH GCP • Pharmaceutical Trials • Biological Trials • Novel Therapies • Companion Animal Trials • Livestock Trials • Multi-centre Trials • Test Permits • Import Licences

Data Management:

• Database Design and Validation • Electronic Data Capture (EDC) and Paper based studies • Data Management Activities and Consultancy

Biostatistics:

• Statistical Input and Design • Randomisations • Statistical Analysis

Quality Assurance:

• Site Audits • Master File Audits • Database Audits (paper and EDC) • Systems Audits

To find out more (including therapeutic areas) please visit: www.ondax-scientific.com



http://www.ondax-scientific.com/



IHS Markit Animal Health Buyer’s Guide: CROs


CRO’s

Klifovet AG

Klifovet AG








• Data entry, data management and statistics. • Electronic Data Capture: STUDYBASE®, the

validated study management software exclusively made for animal studies.







Cebiphar

Cebiphar

Do you need to develop and ensure Life Cycle management of your veterinary drugs, biological, zootechnical & food products?





Cebiphar

Member of the Teranga group Cebiphar 1 rue de la Bodinière 37230 Fondettes France Tel: +33 (0)2 47 42 48 48

Contact: Oliver Roy [email protected] www.cebiphar.com

CEBIPHAR is your trusted partner for:

Multi-site clinical trials for farm & companion animals (according to GCP principles): efficacy, safety, palatability, microbiological studies

On site experimental studies:

TAS, PK, residues, Minimum Inhibitory Concentrations (MIC), Minimum Bactericidal Concentrations (MBC), etc.

Animal models: Large portfolio of models encompassing the major diseases of livestock (lactating cow, cattle, pre-ruminant calves, sheep, swine, poultry, rabbit...) allowing the evaluation of a variety of products (vaccines, antibiotics, NSAIDs, etc.)

Five reasons you can entrust your projects to CEBIPHAR:

1. People: Experienced staff dedicated to your project.

2. Expertise: Over 37 years of experience and more than 800 studies performed.

3. Comprehensive services: - Strategic advice & project management, for both preclinical & clinical studies. - Regulatory consultancy: audit of dossier, regulatory support, writing of parts III & IV. - Laboratory services: analytical development, VICH stability studies, QC, microbiology (microbiological assay of antibiotics, MIC, MBC, collection of field strains).

4. Animal facilities: - On-site experimental facility adapted to multiple animal species. - Partnership with INRA (French National Institute for Agricultural Research) for confinement studies.

5. Rigorous quality system & GLP-GMP accredited environment.

Contacts: Olivier Roy, Director of Veterinary Preclinical & Clinical Department: [email protected] Stéphanie Burger-Prin, Marketing & Commercial Director: [email protected]


http://www.cebiphar.com/






Clinvet

Clinvet

Clinvet is a GCP/GLP accredited Contract Research Organisation (CRO) established in 1999 and specialises in the conduct of laboratory and field-based efficacy, safety and metabolism trials for veterinary health products.

Since inception, Clinvet has conducted more than 1300 studies aiding in the discovery, development and registration of veterinary products worldwide.

Clinvet has two large state of the art research facilities in South Africa and Morocco.

Services offered by Clinvet:

Laboratory in vitro and in vivo efficacy studies as well as safety and metabolism studies for animal medicine. We maintain an extensive bank of parasites (helminths and arthropods) originating from the US, EU and Africa for use in challenges on companion and production animals. Test animals frequently used include rats, rabbits, cats, dogs, goats, sheep, cattle and horses. We offer the following studies:

• Glass vial contact assay • Artificial membrane feeding assay • Proof of concept efficacy • Dose determination and confirmation • Parasite challenge efficacy • Bioequivalence • Pharmacokinetics • Residue depletion • Target animal safety

Clinical trial conduct as well as the following support services for animal clinical field and laboratory studies:

• Project management, monitoring and quality assurance. • Protocol, report writing and case report form

(CRF) design. • Electronic database, design and validation (EDC/Paper). • Data management, biostatistics and

statistical programming. • Serological (IFA and ELISA) and molecular

(qPCR and PCR) diagnostic testing. • Specialised molecular assay development. • Animal genetic profiling, parentage and

mutation screening. • Genomic analysis of parasites.

Clinvet Uitzich Road, Bainsvlei Bloemfontein 9338 South Africa Tel: +27 (0)51 445 2424

[email protected] www.clinvet.com


http://www.clinvet.com/




ERAvet

ERAvet








Löhlein & Wolf Vet Research


Löhlein & Wolf Vet Research is a contract research organization specialized in veterinary clinical field studies conducted in Europe.

Studies: GCP and non-GCP studies in companion and farm animal species, poultry and minor species.

Services: Project management, monitoring, medical writing, translations, selection and set up of study sites, material and drug logistics and management, test permits, QA, data management and statistics, reporting and electronic data capture (Löhlein & Wolf EDC and third-party EDC solutions).

Löhlein & Wolf Vet Research Ickstattstr. 5 80469 München Germany Tel: +49 89 2300 0123 Fax +49 89 2307 6763

Contact: Oliver Wolf and Wolfgang Löhlein







[email protected] www.vet-research.com

Quality: Full featured and audited quality management system. Providing high quality services with a maximum of flexibility.

Network: Strong network of experienced partners, veterinarians, farmers, specialists, clinics and laboratories.

Contacts: Oliver Wolf and Wolfgang Löhlein

BioMedVet Research

BioMedVet Research GmbH

BioMedVet Research is an independent and privately owned GLP-certified contract research organisation with core competence in the field of animal health.

We are located in a rural area in Northern Germany facilitating the conduct of studies not only under laboratory but also under field conditions.

Purpose-built facilities are available on site to accommodate all relevant animal species such as rabbits, dogs, cats, pigs, sheep, goats, cattle, horses and poultry.

Our services for pharmaceuticals, biologicals and feed additives include:

• Pharmacokinetics/Bioequivalence • Residue depletion • Target animal safety/Tolerance • Local tolerance • Efficacy (incl. BSL 2 challenge/infection models)

Our efficient organisation ensures short communication lines, a flexible customer-oriented approach and services tailored to the individual requirements of the product.

BioMedVet Research GmbH Südkampen 31 29664 Walsrode Germany Tel: +49-(0)-51-66-931-98-0 Fax: +49-(0)-51-66-931-98-29

Contact: Dr. Holger Schmidt [email protected]

IDEXX BioAnalytics

IDEXX BioAnalytics

From Pilot Studies to Pivotal Trials, you can count on our IDEXX BioAnalytics clinical support team to help you reduce errors, increase sample quality and decrease turnaround times. Our extensive assay portfolio is your advantage – our centralized lab services provide quality; confident results you can trust.

• Dedicated Project Manager • Global Study Coordination • Customized Sample Collection Kits • VICH GL9 expertise • EDC Software Connectivity

IDEXX BioAnalytics Vet Med Labor GmbH Moerikestrasse 28/1 71636 Ludwigsburg Germany


http://www.vet-research.com/





IDEXX BioAnalytics

Tel: +49 (0) 7141 64 83 585 Fax: +49 (0) 7141 64 83 584

[email protected] www.idexxbioanalytics. eu/reliable-reproducible-results/

• Study Close-out Support

IDEXX BioAnalytics is your strategic partner for reliable, reproducible results whilst accelerating your research through innovative technologies, logistics support and scientific expertise, so you can confidently improve the health and welfare of people and animals.

A global market leader in diagnostics solutions for animal health, water and dairy quality:

• Over 6,500 global employees • Over 400 scientists, pathologists and veterinarians

on staff • Over 60 locations worldwide • Over 280 million invested in R&D in the last 5 years

Moredun Scientific

Moredun Scientific

Moredun Scientific, the commercial arm of the Moredun Group, is a GLP accredited contract research organization with over 25 years of experience in conducting efficacy and safety studies in all species of livestock.

Disease Models: our broad portfolio of infectious disease models coupled with the ability to develop and validate new models supports the registration of veterinary vaccines, anti-infectives, anti-parasitics and feed additives.

State of the art animal facilities: GLP accredited animal accommodation ranging from conventional farm accommodation, to specific pathogen free (SPF), Category 3 containment or gnotobiotic units.

Laboratory facilities: we can support all aspects of safety and efficacy studies.

Target animal safety studies: we conduct safety and tolerance studies in compliance with relevant international guidelines for pharmaceuticals, biologicals and feed additives.

Rigorous quality systems: our independent Quality Assurance department has expertise in GLP, VICH-GCP and GMP. All studies are conducted to meet regulatory guidelines.

Access to relevant expert scientists: internationally recognised scientists within the Moredun Group provide unique guidance to advance projects.

Moredun Scientific Pentlands Science Park Bush Loan Penicuik, Near Edinburgh, EH26 0PZ, UK Tel:+44 (0)131 445 6206

[email protected] www.moredun-scientific.com



http://www.idexxbioanalytics.eu/reliable-reproducible-results/




http://www.moredun-scientific.com/




Amatsi Group

Amatsi Group


WE PROVIDE:

• BIOSERVICES: (In life studies and Bioanalysis): PK and ADME studies, Safety studies (residues, TAS), some efficacy models.

• PHARMACEUTICAL ANALYSIS SOLUTIONS: (Development & validation of analytical methods, VICH stability studies, Contract cGMP QC).

• FORMULATION DEVELOPMENT & MANUFACTURING: (small-batch-focused).


Under GLP and GMP environment (EMA, FDA compliance).

OUR KEY ASSETS:





CMC-RA team. • Mastering both US & EU veterinary guidelines.

OUR ADDED VALUES:









• Project management • Registration expertise - NCE’s & generics • Dose optimization • GLP/GCPv compliant test facilities

Veterinary Research Management Ltd. The Mews Studio, Portland Road, Malvern







Worcs. WR14 2TA UK

Tel: +44 1684 568998 or +44 7968 696683


• Dose determination, dose confirmation, safety, efficacy, residues, bioequivalence & pK studies in livestock & companion animals.





Triveritas

Triveritas




Triveritas Head Office: Bank Barn How Mill, Brampton Cumbria CA8 9JY UK Tel: +44 (0) 845 123 2888


Farma Research Animal Health

Farma Research Animal Health BV

Farma Research Animal Health B.V.: An independent, GLP accredited, CRO. More than 25 years specialised in the performance and organisation of veterinary projects:

Test products:Veterinary medicines, Feed additives

Quality: GLP, VICH-GCP

Studies:

Farma Research Animal Health BV Toernooiveld 300-H









6525 EC Nijmegen The Netherlands Tel: +31 (0)24 350 55 74

Contact: Hans van Hattum [email protected] www.frah.nl

• Preclinical studies: Bioequivalence, tissue residue, milk residue, target animal safety, pharmacokinetic, dose determination/confirmation, etc.

• Field trials: Efficacy, safety

Target species: Dog, cat, (dairy) cattle, sheep, horse, pig, poultry, birds.

Bio-analytics: Plasma, tissues, milk, egg, faeces, etc.

Regulatory affairs: Consultancy, dossiers, expert reports

Pharmacovigilance: QPPV, PSUR, DDPS

Guidelines: Projects according to actual EMA and VICH-GCP Guidelines.

Vetspin

Vetspin Srl

Vetspin is a GLP and GCP accredited CRO specialised in studies of safety and efficacy on farm animals, including cattle, pig, sheep, poultry (chicken, turkey, duck, guinea fowl) and rabbit.

• Target animal safety, pharmacokinetic, residue depletion, dose determination on infected animals.

• Development and validation of analytical methods for veterinary drugs on plasma, tissues (liver, kidney, fat, fat+skin, muscle, other tissues), milk, eggs, manure.

• Data Analysis (Biostatistics) • Regulatory affairs: Dossiers, Expert Reports

Vetspin Srl Via Tolara di Sopra 5040064 Ozzano dell' Emilia (BO) Italy Tel: +39 (0)51 2097500

[email protected] www.vetspin.com

Ondax Scientific

Ondax Scientific SL



ONDAX Scientific is an independent Contract Research Organisation (CRO) specialised in providing Europe-wide Clinical Trial Services to the animal health industry. Our Clinical Trial Services include test permit applications, study set-up, trial monitoring, auditing, data entry, data analysis and study report writing both in companion animals and livestock. We are highly experienced conducting a wide range of field studies to evaluate the efficacy and safety of Pharmaceuticals and Biologicals both at national and multinational level in several therapeutic areas. We operate in a highly responsive,

Ondax Scientific SL Aptdo. 336 20280 Hondarribia Gipuzkoa Spain Tel: +34 943 646 087 Fax: +34 943 646 158


http://www.frah.nl/


http://www.vetspin.com/




Ondax Scientific SL


flexible manner to suit Sponsor requirements meeting targets in a timely and cost-effective manner.


Clinical Trials:

• VICH GCP • Pharmaceutical Trials • Biological Trials • Novel Therapies • Companion Animal Trials • Livestock Trials • Multicentre Trials • Test Permits • Import licences

Data Management:


Biostatistics:


Quality Assurance:








IHS Markit Animal Health Buyer’s Guide: Education & Training


Education & Training

Klifovet AG

Klifovet AG



















• Project management • Registration expertise - NCE’s & generics • Dose optimization







The Mews Studio, Portland Road, Malvern, Worcs. WR14 2TA UK Tel: +44 1684 568998 or +44 7968 696683


• GLP/GCPv compliant test facilities • Dose determination, dose confirmation, safety, efficacy,

residues, bioequivalence & pK studies in livestock & companion animals.





Cyton Biosciences


Expertise in depth




















Triveritas

Triveritas









IHS Markit Animal Health Buyer’s Guide: IT Services


IT Services

Klifovet AG

Klifovet AG
















Kynetec

Kynetec

As the leading research specialist in animal health, Kynetec helps companies around the world understand the dynamics of their industry, from livestock producers to pet owners, veterinarians, the sales channel or the food chain. We turn





Kynetec



research into business opportunities and enable clients to create winning strategies.


Everything we do is delivered by a team of specialists who understand the challenges impacting the animal health industry. Our coverage extends to major and niche sectors of our industry, where we regularly undertake research projects in more than 70 countries. With our international team of experts located around the world, no matter where you are, we can help

Triveritas

Triveritas






Ondax Scientific

Ondax Scientific SL



ONDAX Scientific is an independent Contract Research Organisation (CRO) specialised in providing Europe-wide








Ondax Scientific SL

Ondax Scientific SL Aptdo. 336 20280 Hondarribia Gipuzkoa Spain Tel: +34 943 646 087 Email: +34 943 646 158


Clinical Trial Services to the animal health industry. Our Clinical Trial Services include test permit applications, study set-up, trial monitoring, auditing, data entry, data analysis and study report writing both in companion animals and livestock. We are highly experienced conducting a wide range of field studies to evaluate the efficacy and safety of Pharmaceuticals and Biologicals both at national and multinational level in several therapeutic areas. We operate in a highly responsive, flexible manner to suit Sponsor requirements meeting targets in a timely and cost-effective manner.


Clinical Trials:

• VICH GCP • Pharmaceutical Trials • Biological Trials • Novel Therapies • Companion Animal Trials • Livestock Trials • Multicentre Trials • Test Permits • Import Licences

Data Management:


Biostatistics:


Quality Assurance:








IHS Markit Animal Health Buyer’s Guide: Manufacturer


Manufacturer

Klifovet AG

Klifovet AG










• Import and manufacturing of veterinary medicinal products and clinical study supplies to GMP: re-packaging, labelling, storage, EU QP release










Nordson

Nordson EFD

With its 2017 acquisition of Plas-Pak Industries, Inc., Nordson EFD now offers best-in-class Dial-A-Dose™ and Posi-Dose® disposable dosing syringes used for primary packaging and drug delivery of creams, gels, and pastes in the animal health industry. The world’s leading manufacturer of fluid packaging and precision dispensing systems since 1963, Nordson EFD offers worldwide support with offices in more than 40 countries, plus global stocking warehouses and technical support. Nordson EFD

40 Catamore Blvd., East Providence RI 02914 USA Toll Free: 800-556-3484 Tel: +1 401-431-7000

[email protected] www.nordsonefd.com/ AnimalHealth

Amatsi Group

Amatsi Group


WE PROVIDE:






OUR KEY ASSETS:

• Facilities for farm and companion animals both in the US and in France (total 7 400 m2 / 80,000sq ft).


• AAALAC accreditation • 6 D.V.M. on site





http://www.nordsonefd.com/AnimalHealth

http://www.nordsonefd.com/AnimalHealth






Amatsi Group

• In life & bioanalytical capacities at the same site in France.

• Option for full project management supported by our CMC-RA team.

• Mastering both US & EU veterinary guidelines

OUR ADDED VALUES:



Ashish Life Science

Ashish Life Science Pvt Ltd

Ashish Life Science (ALS), India, is an Organization with over a decade of experience in veterinary formulation manufacturing. Currently we export to more than 50 countries globally. We are one of the leading Contract manufacturing organization catering to global clients.

Facility Approvals Manufacturing facility is approved by following authorities:

• EU GMP • APVMA (Australia) • All other important African countries approvals.

Manufacturing ALS owns state-of-the-art manufacturing facility located in MIDC, Tarapur, in the state of Maharashtra, 100 km away from Mumbai airport with the following dosage forms:

• Tablet and Oral Liquid • Oral Powder and Oral Paste • Sterile Liquid Injections

Contract Manufacturing Organization (CMO) ALS undertakes contract manufacturing for many international and national organizations for the supply of tailor-made solutions. We provide one-stop solution to all animal health pharmaceutical and nutraceutical products.

Product Development Service From the product concept, through formulation and development, to production, our team of experts is capable of producing cost effective, high quality products with superior performance by applying modern technology and technical expertise at every step in the process. We not only help our clients to deliver a better product but also help to bring it to market faster. Process of product development is as follows:

• Formulation and Development • Validation of Analytical Methods • Stability study conducted according to ICH guidelines.

Ashish Life Science Pvt Ltd Nordson EFD 213, Laxmi Plaza New Link Road Andheri (W) Mumbai - 400053 India. www.ashishlifescience.com bdm.cm@ashishlife science.com

http://www.ashishlifescience.com/






Ashish Life Science Pvt Ltd

Regulatory Service As per regulatory guidelines we provide all relevant documents for dossier preparation as per authority's requirements.

Key Service features:

• EU GMP site for Tablet, Liquid, Oral Paste and Powders • CMO business & ready to buy existing M.A. • Collaboration with EU partners for site transfer projects &

Collaborative product development.

Dechra

Dechra Pharmaceuticals Manufacturing

Dechra Pharmaceuticals Manufacturing is the manufacturing business of Dechra Pharmaceuticals PLC, operating from two European sites at Bladel, NL and Skipton, UK.

Dechra Pharmaceuticals Manufacturing provides a comprehensive range of contract pharmaceutical services.

Our mission is to provide an excellent service, developing and supplying quality products to our customers worldwide.

We are a complete service provider, offering product development through manufacturing and packing to QP release, supported by highly qualified staff, trained to the highest standard.

The Bladel site is dedicated to veterinary pharmaceuticals and the state of the art, cGMP, IGZ approved facility has a wide range of capabilities from small volume and development scale batches to large volume production for food producing animals.

It manufacturers aseptically filled injections, oral solutions, powders and medicated premixes, packed into a range of sizes of vials, bottles, sachets and bags.

Ongoing investment in our factory at Skipton, has created a, well equipped, MHRA and FDA approved cGMP facility that produces a diverse range of dosage forms and wide scale of volumes and batch sizes, including scale-up and commercial batch production.

Products produced include tablets, capsules, ointments, creams, gels, liquids and terminally sterilized injections, packed into blisters, pots, sachets, tubes, dispensers, bottles and vials.

As well as the accreditations (listed above) we have achieved certification to ISO 14001 environmental standard, and are licensed to manufacture IMPs, Specials and Controlled Drugs.

The combined sites offer a full range of manufacturing services to the veterinary industry.

Dechara Pharmaceuticals Manufacturing www.dechra.co.uk/

http://http/www.dechra.co.uk/




Triveritas

Triveritas









IHS Markit Animal Health Buyer’s Guide: Market Research


Market Research

Klifovet AG

Klifovet AG
















Kynetec

Kynetec

As the leading research specialist in animal health, Kynetec helps companies around the world understand the dynamics of their industry, from livestock producers to pet owners, veterinarians, the sales channel or the food chain. We turn





Kynetec



research into business opportunities and enable clients to create winning strategies.


Everything we do is delivered by a team of specialists who understand the challenges impacting the animal health industry. Our coverage extends to major and niche sectors of our industry, where we regularly undertake research projects in more than 70 countries. With our international team of experts located around the world, no matter where you are, we can help

Veterinary Insights

Veterinary Insights






Veterinary Insights Unit 5, The Old Stables Hoadlands Farm London Road Handcross RH17 6HB Tel: 01403 800 135












Triveritas

Triveritas






Ondax Scientific

Ondax Scientific SL



ONDAX Scientific is an independent Contract Research Organisation (CRO) specialised in providing Europe-wide Clinical Trial Services to the animal health industry. Our Clinical Trial Services include test permit applications, study set-up, trial monitoring, auditing, data entry, data analysis and study report writing both in companion animals and livestock. We are highly experienced conducting a wide range of field studies to evaluate the efficacy and safety of Pharmaceuticals and Biologicals both at national and multinational level in several therapeutic areas. We operate in a highly responsive, flexible manner to suit Sponsor requirements meeting targets in a timely and cost-effective manner.


Clinical Trials:


Data Management:











Ondax Scientific SL


Biostatistics:


Quality Assurance:





IHS Markit Animal Health Buyer’s Guide: Marketing Sales


Marketing Sales

Klifovet AG

Klifovet AG
















Veterinary Insights

Veterinary Insights






Veterinary Insights

Veterinary Insights Unit 5, The Old Stables Hoadlands Farm London Road Handcross RH17 6HB Tel: 01403 800 135






Triveritas

Triveritas
















Produkt + Markt

Produkt + Markt

Deep understanding of markets and customers – that's what we stand for since 1970. PRODUKT + MARKT has extensive experience in animal health and agribusiness marketing research.

With our interdisciplinary team we provide outstanding expertise for the lifestock and companion animal markets of the world. Reliable – actionable – cost effective.

Give us a call to explore the opportunities.

Produkt + Markt Otto-Lilienthal-Str. 15 D-49134 Wallenhorst Germany Tel: 00 49-5407-885-212

Contact: Karl-Georg Herbert [email protected] www.pundm.de


http://www.pundm.de/


IHS Markit Animal Health Buyer’s Guide: Recruitment


Recruitment

Klifovet AG

Klifovet AG
















VET Recruiter

VET Recruiter

The VET Recruiter® is an Executive Search and Recruitment Firm specializing in the Animal Health, Animal Science and Animal Nutrition Industries as well as the Veterinary Profession. In addition to Direct Hire Placements, we handle Contract Staffing.





VET Recruiter

VET Recruiter 7107 S. Yale Ave #315 Tulsa OK 74136 USA Tel: 918-298-7025 / or 800-436-0490

[email protected] www.thevetrecruiter.com

Our mission is to help Animal Health Companies and Veterinary Businesses acquire top talent which helps them increase their bottom line on a global basis, while helping Animal Health and Veterinary professionals attain career-enhancing opportunities that allow them to achieve the quality of life they seek.

With our singular focus in the field of Animal Health, Animal Science and Animal Nutrition as well as the Veterinary Profession, there is no recruiting firm better connected in this market. Whether you need to hire one person or a team of people, or are looking to make your next career move, no one can help you achieve your goals faster and more effectively than The VET Recruiter®.

We partner with employers that need to find talented people to help their business growth and become more profitable. Our clients range in size from Fortune 100 companies, to midsize and start-ups as well as veterinary hospitals throughout the United States and Canada. We help our clients locate and hire the best talent for their specific needs. We also accept select searches outside of the United States and Canada and have experience in Europe and in other parts of the world.

Our goal is long-term partnerships with employers to resolve hiring challenges by providing the best candidates in the marketplace and not the best candidates who are ‘looking’ for a position. We find hidden candidates who are not in the job market but are willing to make a strategic move for the right opportunity. These are the individuals who have to be headhunted because they are not reading job advertisements.

Our passion is to solve problems and to make a difference in the lives of people.

De Causmaecker & Associates


De Causmaecker & Associates – House of Consultants is one of the few HR consulting firms, based in Germany, whose associates are executive search professionals, and are themselves true professionals with managerial experience. Life Science, including Animal Heath and Animal Nutrition, is a cornerstone in our portfolio. We have been designing national and international recruitment solutions for our clients for over 20 years. Being experienced, innovative and creative we very much hope to convince you to join us as a loyal client or as an interested candidate in the near future!

Wolfgang Müller is our Animal Health Associate with an international career path up to Vice President and general management. He gained in-depth experience in leading and developing intercultural teams supported by long-term

Contact: Wolfgang Müller Mobile: +49 151 14318689

[email protected] www.houseofconsultants. de/en/index.php


http://www.thevetrecruiter.com/


http://www.houseofconsultants.de/en/index.php






assignments in Scandinavia, North Asia and South Europe. He knows all aspects of the different industry and portfolio challenges and opportunities and prepared to provide the required solution for you.

Companies and candidates are invited to contact Wolfgang Müller via his Email: [email protected] or Mobile: +49 151 14318689.

For further information, please use our website: www.houseofconsultants.de/en/index.php

Triveritas

Triveritas











IHS Markit Animal Health Buyer’s Guide: Regulatory


Regulatory

Klifovet AG

Klifovet AG
















ERAvet

ERAvet






ERAvet







Amatsi Group

Amatsi Group


WE PROVIDE:






OUR KEY ASSETS:












Amatsi Group




CMC-RA team. • Mastering both US & EU veterinary guidelines

OUR ADDED VALUES:



Cyton Biosciences


Expertise in depth


















Triveritas

Triveritas






Estendart

Estendart Ltd

Estendart Ltd is NZ’s leading company for regulatory-based studies conducted to GLP (OECD) and GCP (VICH) standards. Estendart Ltd (est 1986) is alongside Massey University’s Vet School with direct access to the extensive research facilities, farms and veterinary expertise. Proof-of-concept, pre-clinical and clinical studies (multi-site) are undertaken in all food-producing and companion animals. These focus on efficacy, safety and residue (food-producing) evaluations. Services include animal models for the evaluation of medical devices and determination of the toxicology of compounds with biological activity. Estendart provides a full service commencing with arranging the importation of test items, protocol development, quality assurance, statistical analysis and reporting. All studies comply with NZ law on animal welfare. Although based “downunder” we are still only a dotcom away.

Estendart Ltd Aviation Way, Poultry Farm Road, Palmerston North, 4442 New Zealand Tel: +64 (0) 6 3500770

[email protected] www.estendart.com/

Farma Research Animal Health


Farma Research Animal Health B.V.: an independent, GLP accredited, CRO. More than 25 years specialised in the performance and organisation of veterinary projects:

Test products: Veterinary medicines, Feed additives




http://www.estendart.com/





Farma Research Animal Health BV Toernooiveld 300-H 6525 EC Nijmegen The Netherlands Tel: +31 (0)24 350 55 74

Contact: Hans van Hattum [email protected] www.frah.nl

Quality: GLP, VICH-GCP

Studies:

• Preclinical studies: bioequivalence, tissue residue, milk residue, target animal safety, pharmacokinetic, dose determination/confirmation, etc.

• Field trials: efficacy, safety

Target species: dog, cat, (dairy) cattle, sheep, horse, pig, poultry, birds.

Bio-analytics: Plasma, tissues, milk, egg, faeces, etc.

Regulatory affairs: Consultancy, dossiers, expert reports

Pharmacovigilance: QPPV, PSUR, DDPS

Guidelines: Projects according to actual EMA and VICH-GCP Guidelines

Ondax Scientific

Ondax Scientific SL



ONDAX Scientific is an independent Contract Research Organisation (CRO) specialised in providing Europe-wide Clinical Trial Services to the animal health industry. Our Clinical Trial Services include test permit applications, study set-up, trial monitoring, auditing, data entry, data analysis and study report writing both in companion animals and livestock. We are highly experienced conducting a wide range of field studies to evaluate the efficacy and safety of Pharmaceuticals and Biologicals both at national and multinational level in several therapeutic areas. We operate in a highly responsive, flexible manner to suit Sponsor requirements meeting targets in a timely and cost-effective manner.


Clinical Trials:


Data Management:

• Database Design and Validation




http://www.frah.nl/







Ondax Scientific SL

• Electronic Data Capture (EDC) and Paper based studies • Data Management Activities and Consultancy

Biostatistics:


Quality Assurance:





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