MedPharm has an outstanding record of compliance with regulatory authorities. Customers can have a very high level of confidence that the manufacture and testing of their products at MedPharm facilities will meet all regulatory compliance requirements where required.
MedPharm has current certificates for working under both GLP and cGMP. It is licensed by the MHRA to manufacture clinical trial supplies worldwide. The most recent regulatory inspection conducted by the UK MHRA in January 2017 returned no critical or major observations.
Furthermore, MedPharm uses its experience to support customers in navigating their products through the complexities of a regulatory approval whether that be;
- creating and implementing programmes that result in approval of generic products with in vitro bioequivalence testing only
- including innovative and validated activity models which enhance the trust regulators have in the submission
- providing submission data and scientific development packages delivered right first time thereby shortening the time to regulatory review
- credible consultancy at scientific advice meetings founded on having developed over 40 products currently on the US or European markets