National and International regulatory advice on the development and commercial production of biological products is provided by a former US FDA CBER reviewer and certified FDA inspector, trained in regulatory affairs, product manufacturing and testing and facility inspections.

The FDA and ICH guidance documents support a strategic framework for biotechnology product development. Successful product approval follows from a detailed practical appreciation of regulatory and manufacturing operations gained from both sides of the “regulatory fence”.

B.R.A. (Edinburgh ) specializes in the preparation and review of regulatory applications (IND,CTX, BLA & MAA), product development strategies, facility and mock pre-approval inspections, process validation packages, GLP and GMP audits and Quality Systems audits.