better medicinesYour bridge to

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At a GlanceAnapharm Bioanalytics is a client-oriented, GLP-certified,FDA-inspected, GCP-compliant and ANVISA-certified bioanalyticalcontract research organization (CRO) offering comprehensive highquality bioanalytical services to the pharmaceutical, biotechnologicaland generic industry worldwide.

PHASE I-III & BIOEQUIVALENCEOur global reach allows us to providefull service outsourcing solutions toconduct preclinical, Phase I-III clinicaltrials, PK/PD and BA/BE studies forregistration worldwide, as well as nonregulated discovery projects.

INDUSTRY LEADERWe offer 30+ years of experience inanalytical method development,validation and sample analysis of bothsmall and large molecules in a variety ofbiological matrices, using state-of-the-artLC-MS/MS and Ligand Binding Assay(LBA) technology platforms.

500+bioanalytical methods

1,300+studies performed

250,000+samples per year

GENERICS

LARGE MOLECULESOLIGONUCLEOTIDES

PEPTIDESMONOCLONALANTIBODIES

PROTEINS

BIOSIMILARS

IMMUNOGENICITY

SMALL MOLECULES

BIOMARKERS

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ServicesSMALL MOLECULE BIOANALYSISA team with more than threedecades of experience in bioanalysisand specialized in LC-MS/MSprovides outstanding expertise tolead you through the developmentof any small molecule drugcandidate. • New Chemical Entities (NCE) • Generics • Biomarkers

LARGE MOLECULE BIOANALYSISWe offer an array of Ligand BindingAssays (LBA) and LC-MS/MS technologyplatforms tailored to supportdevelopment programs of biologicsfrom early preclinical throughPhase I-III clinical stages. • Peptides • Biosimilars • Proteins • Oligonucleotides • Monoclonal • Biomarkers Antibodies

COMPREHENSIVE LC-MS/MS & LBA BIOANALYTICAL SERVICES

METHODDEVELOPMENT & VALIDATIONAnalytical method development andvalidation of proprietary assays, aswell as method transfer, optimizationand cross-validation ofsponsor-supplied methods.

SAMPLE ANALYSISQuantitative sample analysis ofsmall and large molecules forclinical and non-clinical studies ina variety of human and animalbiological fluids and tissues.

IMMUNOGENICITYImmunogenicity testing foranti-drug-antibodies (ADA) safetyassessment following a tieredapproach including ADA screeningand positive ADA confirmation.

REGULATORY AFFAIRSOur team will help you during themarketing authorization procedureby addressing all queries receivedfrom health authorities worldwide toensure a smooth regulatory filing.

BIOMARKERSTargeted biomarker assaydevelopment, validation andmeasurement in non-clinical andclinical samples.

GENERICSAn extensive portfolio of 500+assays is readily available to supportbioavailability & bioequivalence(BA/BE) and drug-drug interactionstudies.

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FROM EARLY PRECLINICAL THROUGH PHASE I-III STUDIES UNTILREGULATORY APPROVALWhether your drug candidate is a new chemical entity, a new biologic, ageneric or a biosimilar, we shall guide you from early discovery throughnon-clinical and clinical stages (including pharmacokinetic & pharmacodynamicas well as bioavailability & bioequivalence studies) until successfulregulatory approval is attained.

EARLY DEVELOPMENT CLINICAL DEVELOPMENT DRUG APPROVAL

• Discovery• Preclinical

• Phase I, Phase II, Phase III• PK/PD - BA/BE

• Regulatory Approval• Safety & Surveillance

EXPERTISE IN COMPLEX BIOANALYSISWe offer broad experience in challenging projects involving complexbioanalysis in a variety of biological matrices.

Complex bioanalysis:• High sensitivity assays

with sub-pg/mL LLOQ• Endogenous compounds

• Chiral compounds • Light and temperature sensitive analytes

In an array of human and animal matrices: blood, plasma, serum, urine, feces and tissues of various species

Challenging projects:• Orally inhaled drugs• Long-acting injectables

• PK studies in patients • Steroid hormones

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Main StrengthsOur dedicated staff ensures that all our studies meet Sponsor’s requirementswith regards to quality, performance, reliability and timelines.

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High Quality StandardsA strong quality culture is secondnature at Anapharm Bioanalyticsand is a key factor in ensuring asolid quality system in compliancewith international guidelines.

Outstanding RegulatoryTrack RecordOur impeccable reputation and theinspections undertaken by EU HealthAuthorities, FDA and ANVISA ensurea smooth dossier registrationprocedure worldwide.

Client OrientedWe aim to exceed clients’ expectations. For this reason, ourhighly trained staff is committed toyour project from the very first minuteuntil its finalization, in order to helpyou achieve your long-term goals.

We Meet Your DeadlineOur high throughput capacity andcommitted staff provide us withthe necessary flexibility to offercompetitive timelines for methoddevelopment, validation andsample analysis.

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Extensive Experience& Solid Know-HowA team of experts with more than30 years of experience in thebioanalytical field delivers robustassays and reliable data to supportpreclinical and clinical phases.

Worldwide Regulatory SupportOur clients benefit from the vastexperience and fast assistance of ourscientists in responding queries fromhealth authorities in North & SouthAmerica, Europe, Africa, Middle East,South East Asia, Australia and Japan.

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Team & ExperienceLeading

bioanalysissince the1980’s

Highly trained scientists with over 30 years ofexperience in bioanalysis ensure maximum level ofexpertise and quality standards to support ourclients at any stage of drug development. Each of our senior staff has more than 10 years ofproven bench experience.

Recruitmentof highly qualifiedscientists

Intensive training of personnel(including sample handling,sample extraction, run set-up,data processing and reporting)

Maximum levelof expertiseand qualitystandards

Each study has an assigned studydirector in charge, who leads ateam of experts dedicated toyour project.

We ensure direct and easycommunication with the studydirector throughout the projectin order to meet your individualrequirements and provide youwith fast assistance and timelyupdates.

The knowledge, experience,attention to detail and dedicationof Anapharm Bioanalytics’ staffhave created an effective andenriching work environment.

The relationship with ourclients is essential to us; wewant you to feel confidentabout our work.

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Facilities, equipment& softwareAnapharm Bioanalytics offers a state-of-the-art laboratory, equippedwith the most advanced High Performance Liquid ChromatographyMass Spectrometry (LC-MS/MS) and Ligand Binding Assay (LBA) technologyplatforms, tailored to meet all scientific, regulatory and quality requirementsin support of the drug development efforts of the pharmaceutical industry.

13 LC-MS/MS instruments:• 3 x Sciex Qtrap 6500/UPLC• 2 x Sciex Qtrap 5500/UPLC• 2 x Sciex API 5000/UPLC• 6 x Sciex API 4000 triple quadrupoles

Enzyme Linked ImmunosorbentAssay (ELISA) with thefollowing readouts:• Colorimetric• Chemiluminescence• Fluorescence

1,500 m2 of GLP laboratory space with controlled access.

Laboratory Information Management System (LIMS).

4ºC, -20ºC & -80ºC refrigerators and freezers monitored 24/7.

Storage capacity for 300,000+ samples and reliable sample tracking.

On-site GLP archives with restricted access, controlled environment and fire protection.

Robotics sample handling and extraction technology.

Multi-purpose laboratory for special projects, such as processing of light sensitive samples.

Reference standards room with restricted access.

Emergency electrical supply.

Two Uninterrupted Power Supply units (UPS).

LABORATORY FACILITIES & SOFTWARE

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Quality Assurance

GLP-CERTIFIED, FDA-INSPECTED, GCP-COMPLIANT AND ANVISA-CERTIFIEDAnapharm Bioanalytics has a robust quality system to ensure delivery ofconsistent, reproducible and reliable data required for international registration.

GCPGOO

D CLINICAL PRACTICESIN S P E C T E DINSPECT

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Quality is of utmost importance at Anapharm Bioanalytics. All analytical work andprocesses are conducted in accordance with Standard Operating Procedures (SOPs)in strict compliance with Good Laboratory Practices (GLP) and Good ClinicalPractices (GCP). These SOPs are constantly updated to comply with internationalregulatory requirements.

Led by a Quality Assurance Director with over 20 years’ experience in the field,Anapharm Bioanalytics has its own independent Quality Assurance Unit (QAU), thatensures strict compliance with applicable guidelines and integrity of study data bycontinuous monitoring, process improvement and staff training.

Over the past years, Anapharm Bioanalyticshas established itself as a world-class provider ofbioanalytical services for international registration.

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Quality AssuranceThe QAU is an integral component of every study, and systematically monitorseach one of them from analytical protocol and method validation, throughexperimental work in sample analysis, data management and final analyticalreport. In addition, the QAU conducts process-based and facility audits.

The continuous inspections undertaken by Health Agencies as well as auditsfrom pharmaceutical and biopharmaceutical companies, together with theefforts of our Quality Assurance Unit, contribute to constantly improving thelevel of quality, integrity and compliance achieved at Anapharm Bioanalytics.

METHODVALIDATION

SAMPLEANALYSIS

DATAMANAGEMENT

ANALYTICALREPORT

STUDYPROTOCOL

100+sponsor audits

15+regulatoryinspections

As a leading provider of bioanalytical services weaim to become a valued partner for your productresearch, development and registration.

C/ Encuny 22, 2nd floor08038 Barcelona - SpainPhone: +34 93 223 86 36contact@anapharmbioanalytics.com

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