GMP Pharmaceutical Analysis Laboratories

Intertek provides cGMP compliant pharmaceutical analysis services that meet the requirements of regulatory authorities worldwide. Laboratory services supporting GMP and CMC requirements range from early development characterization, formulation support analysis, stability testing and method development and method validation through to GMP batch release testing.

Our experienced scientists can support your development or manufacturing activities for both small molecule pharmaceuticals and biopharmaceuticals such as proteins, monoclonal antibodies and vaccines. Our GMP laboratory teams have extensive experience with drug delivery systems, drug device combinations and a wide range of medical devices.

cGMP Compliant Analytical Laboratories:

• Intertek Pharmaceutical Services (Whitehouse, NJ, USA) specialized in cGMP analytical research and development, inorganic and organic elemental analysis, stability studies and extractables and leachables
• Switzerland Analytical Laboratory, Basel, Switzerland. The laboratory is equipped with state-of-the-art instrumentation, capable of performing chemical trace analysis, reverse engineering, complex analyses, substance identification and method development. The laboratory is Good Laboratory Practice (GLP) and cGMP compliant and was added to the WHO list of Prequalified Quality Control Laboratories in 2014
• Intertek Pharmaceutical Services Manchester (Manchester, UK) specialized in CMC analytical services, cGMP analysis and advanced characterization for pharmaceuticals and biopharmaceutical or biotechnology products. Services include cGMP Nuclear Magnetic Resonance Spectroscopy (NMR) services, GMP batch release testing and stability studies
• Intertek Melbourn (Melbourn, UK) specialized in analytical and formulation development with core expertise in inhaled and nasal medicines. Services include analytical services, stability storage studies and formulation development with GMP clinical scale production capabilities

Our scientists are professional, highly trained individuals with years of industry experience in method development and validation that spans a wide scope of analytical technology. Our teams around the world are committed to the success of every client.