EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010 - Bioanalytical Lab & Top CRO for Large Molecule Bioanalysis

Cell-Based Assays

Learn how BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay (CBA) requirements.

Pharmacokinetics & Pharmacodynamics (PK/PD)

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

Case Studies

Learn why we’re a trusted partner to 22 of the top 25 global pharma and biotech companies.

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.

SPEAK TO A SCIENTIST

Featured Expert

Todd Lester, Associate Director

Steven Michael, Ph.D., Senior Vice President and Chief Operating Officer

Nathan Rudemiller, Ph.D., Associate Director

Michelle Miller, Ph.D. DABT, Associate Director

Marianne Scheel Fjording, Ph.D., Scientific Officer

Luke Armstrong, Ph.D., Manager II

Linda Robbie, Ph.D., Vice President and General Manager, Boston Operations

Laura Lassen, Director

Krystal Alligood, Associate Director

Kathryn Lindley, Vice President, Operations

Jim McNally, Ph.D., Chief Scientific Officer

Jessica Weaver, Manager II & Bioanalytical Project Manager

Jennifer Zemo, Ph.D., Director

Jennifer Johnson, Manager I

Jennifer T. Durham, Ph.D., Associate Director of Scientific Services, BioAgilytix

Jeff Patrick, Ph.D., Director of GMP Operations, BioAgilytix

Janina Hajek, Ph.D., Principal Investigator

Janett Schwarz, Ph.D., Principal Investigator

Imke Müller, Ph.D., Director, Principal Investigator

Frank Wischnewski, Ph.D., Associate Director

Frank Horling, Ph.D., General Manager, Europe

Florian Anlauff, Ph.D., Principal Investigator

David Rusnak, Director, Bioanalytical Operations

Dave Williams, Ph.D., Vice President, Bioanalytical Operations

Daniel Worms, Ph.D., Associate Principal Investigator

Chad Briscoe, Ph.D., Vice President, Business Development Europe

Carla Mejia, Manager II

Carla Gibbons, Senior QA Director

Anne Timmerman, Ph.D., Associate Principal Investigator

Anita Simkins, Senior Vice President, Global Quality Assurance

Amanda Hays, Ph.D., Scientific Officer

Afshin Safavi, Ph.D., Founder & Board Member

Cell-Based Assays

Learn how BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay (CBA) requirements.

Pharmacokinetics & Pharmacodynamics (PK/PD)

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

Case Studies

Learn why we’re a trusted partner to 22 of the top 25 global pharma and biotech companies.

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.

SPEAK TO A SCIENTIST

Platforms

Services

USA HQ

2300 Englert Drive

Durham, NC 27713

919-381-6097

Fax 919-381-6099

Boston Laboratory

1320 Soldiers Field Road

Boston, MA 02135

617-456-0700

Fax 617-456-0701

San Diego Laboratory

9050 Camino Santa Fe

San Diego, CA 92121

858-652-4600

Fax 858-652-4699

European HQ

Lademannbogen 10

22339 Hamburg, Germany

+49 40 526779 0

Brisbane Laboratory

37 Kent St, Woolloongabba

Queensland, 4102, Australia

Melbourne Laboratory

85 Commercial Road, Melbourne

Victoria, 3004, Australia

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