Charles River Biopharmaceutical Services (BPS) offers a broad and unique array of expertise in international regulatory guidelines as applied to biologics. BPS provides guidance to biotechnology companies on Chemistry, Manufacturing and Controls (CMC) regulatory compliance designed to lead biopharmaceutical products to successful approvals internationally. With over 15 years of experience with the US Food and Drug Administration (FDA); the European Medicines Agency (EMA); and the Japanese Ministry of Health, Labour and Welfare (MLHW), our technical and quality assurance personnel can help to accelerate the development of your biologic to meet regulatory compliance in the current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) testing and manufacturing environment.
Many regulatory guidelines must be followed and many testing regimens must be developed for you to meet the specific requirements of the territory in which you intend to market your product. BPS can assist in the design of studies to meet the guidelines for North America, Europe and Asia and help you understand the regulatory thought processes behind these guidelines. Links to commonly cited guidelines are given below.
- International Conference on Harmonisation (ICH)
- Q5A(R1) (Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - 1999)
- Q5B (Quality of Biotechnological Products: Analysis of the expression construct in cells used for production of r-DNA derived protein products - 1995)
- Q5D (Quality of Biotechnological Products: Derivation and characterization of cell substrates used for production of biotechnological/biological products - 1997)
For more information on current developments in regulatory guidelines, visit the
Current Regulatory Topics page.