J. Lemmenslaan 24
MPI offers regulatory affairs services in the European Community: – Strategy review – New applications – Post approval procedures – pricing and reimbursement – Dossier updates – Line extensions – Variations – Licence renewals
MPI has extensive experience in medical and technical writing: – Clinical and Non-clinical overviews and summaries – Pharmaceutical expert reports – SmPC – Periodic Safety Update Reports – Ecotoxicology assessments
We have extensive experience in the registration of Active Pharmaceutical Ingredients: CoS – DMF
Areas covered: Domestic Markets, Export Drugs, Clinical Trial Medication, Controlled Substances, Medical Devices ….
MPI also commercialises a sophisticated database for the management of world-wide drug regulatory affairs data.