GMP Consultancy

Good Manufacturing Practice is not a luxury in the pharmaceutical industry: it is imposed by the regulators for the protection of the public, and compliance is necessary for the survival of a company. Whether you are a small virtual company sponsoring clinical studies, or a multi-product manufacturing site you are bound by the GMP rules.

Europe, Japan and the USA all have their own interpretations of what GMP means. Even where requirements have been harmonised through ICH, the agencies interpret these requirements differently: similar, yet in key respects different.

GMP consultancy is the core of our expertise. With over twenty-five years of experience in the regulated pharmaceutical industry, in Europe and overseas, our experts have seen both good and bad practices in all sizes of pharmaceutical companies.

Using a combination of system auditing, process analysis and old-fashioned common sense we can work with you to improve GMP compliance and operational efficiency, thus achieving the dual goals of reducing commercial risk and enhancing patient safety.