eurofins pharma bioanalytical outsourcing partner of choice · outsourcing partner of choice about...
TRANSCRIPT
Eurofins Pharma Bioanalytical
Outsourcing Partner of ChoiceExtensive Experience
• Over 15 years of combined large molecule bioanalytical industry drug development, clinical reporting, and support services
• Proven expertise in navigating regulatory agency requirements
• Experience across all therapeutic areas
With our scientific expertise, and global presence; Eurofins Bioanalytical Services is uniquely qualified to provide clients with reliability you can trust.
Trusted Partner of Choice
The evolution to externalize more bioanalytical support has created opportunities to build even stronger partnerships with a specialist you can trust and to refocus internal resources. Our mission is to extend our clients’ capabilities by combining scientific knowledge, capacity, regulatory expertise and flexibility to provide the trusted, relevant information required for the drug approval process.
Due to these changes in Pharma, there is a need to strategically move more bioanalytical work to a provider with the expertise you need and can trust. With this shift of work from Pharma to CROs, talented bioanalytical scientists at Pharma are also migrating to Eurofins Pharma Bioanalytical Services to generate a great and sustainable partnership.
SCIENTIFIC / TECHNICAL SERVICES
• Method transfers and partial validations
• Develop and implement method development strategies
• Provide remote or on-site bioanalytical expertise to US and International Clients
• Determine the root cause for assay issues observed during method development, method
• Validation and identify suitable solutions
REGULATORY / DATA SERVICES
• Conduct pre-qualification / due diligence, GLP and OECD audits
• Monitor and track ongoing bioanalytical activities at a sponsor partner
• Perform post study data audits
SCIENTIFIC AND BUSINESS PROCESS SERVICES
• Review bioanalytical and site policies and procedures
• Review contracts, method development and sample analysis
study plans and protocols
The Outsourcing Advantage
Global Reach and Capacity
The facility in St. Charles has 52,000 sq. ft. total, with 17,000 sq. ft. of dedicated laboratory space.
Eurofins Pharma Bioanalytics Services US Inc. 15 Research Park Drive, St Charles MO 63304 USA
The facility in Oxford has 14,400 sq. ft. total, with 4,400 sq. ft. of dedicated laboratory space.
Eurofins Pharma Bioanalysis Services UK Limited 90 Park Drive, Milton Park, Abingdon, OX14 4RY United Kingdom
Outsourcing Partner of Choice
About Eurofins Bioanalytical Services
Over 15 years of industry-leading global Scientific Expertise supporting the widest breadth of Biologics’ clinical trials with PK/TK, ADA, Nab and Biomarker assays and sample analyses.
Versatile Performance and Project Management Excellence to adapt to a client’s specific needs. Clinical or preclinical, regulated or non-regulated, assay development, qualification or validation; we custom design our support to match the client’s program.
State-of-the art laboratory facilities in Oxford, UK and St. Louis, USA providing Global Reach and Capacity to address clients’ needs while simultaneously offering regionally-based solutions.
[email protected]/bioanalyticalservices
15 years of Scientific
Experience
Flexibility and
Collaboration
Global Capacity
100+ Analytical Methods & 200K Samples per year
All trademarks mentioned herein are the property of Eurofins or their respective owners. Lit No. EBPS-BA-US-OP-02/2019 Printed in the USA. © 2019 Eurofins Pharma Bioanalytics Services US Inc. Eurofins Pharma Bioanalytics Services US Inc. and Eurofins Pharma Bioanalysis Services UK Limited
are independent members of Eurofins Bioanalytical Services