The general move of the pharmaceutical Industry to outsource its Active Pharmaceutical Ingredient (API) manufacture to suppliers in non-EU regions provides challenges that SKS can assist with. From the interpretation of the EU regulatory framework, to discussions with the Competent Authorities on behalf of the client, and ultimately the preparation of dossiers for submission in the relevant format. SKS has an in-depth understanding of the complex procedures associated with API registration in Europe through the ASMF (or DMF), or via the CEP (Certificate of Suitability) procedures.

Contact us for more information.