Regulatory support

We offer a broad range of comprehensive documentation to support you throughout your regulatory submission and approval process. This includes drug master files, certificates of suitability (CEP), letters of access (LOA), API and excipient registrations, material safety data sheets and Pharmacosmos’ GMP certificates.

Certificates of suitability (CEP) issued by the European Directorate for the Quality of Medicines

Safety Data Sheet

Certificate on GMP compliance

Statement on Good Manufacturing Practices for Dextran API for human use

Statement on Good Manufacturing Practices for Dextran API for veterinary use

Additional regulatory documents available

Please contact us for further certificates and approvals

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