Demands of scientific data supporting drugs’ safety, efficacy and quality from regulatory authorities worlwide are addressed on a daily basis by Medichem’s Regulatory Affairs department. This key staff have long-standing expertise dealing with diverse requirement-based scenarios across the world.
Proof of this….
- About 300 regulatory submissions (DMFs) to the National Regulatory Authorities in the US, Europe, Canada, Australia, Korea, Russia and Japan among others (>45 countries).
- 1 DMF to EMA (European Medicines Agency)
- 13 Certificates of Suitability (CEPs) granted by the European Pharmacopeia.
- USA: Since our first inspection by the FDA in 1985 we have submitted more than 70 DMFs in the USA, of which more than 45 are still active.
- 810 Marketing Authorisations
Our expertise in Regulatory Affairs enables us to meet the growing demands of the world’s Health Agencies with regard to the quality of the Drug Master Files (DMF) and FDF Dossiers. One of the main tasks of the Department is to keep abreast of the Regulations regarding APIs and FDFs to work to ensure that Medichem products are compliant with the worldwide pharmaceutical regulations.
Our Regulatory Affairs department also constantly interfaces with decision-making bodies such as Health Authorities and industry association groups in the European Union and the US.
Beyond the preparation of regulatory documentation, Medichem is ready to support the customer from the registration of the Marketing Authorizations to their approval in order to reach the market as quick as possible.