Regivet has long-term experience evaluating the ASMF (and CEP) documents as part of a complete development project. Assessment of such documents can also be performed as a separate task, e.g. selection of a suitable second API-source for an existing product. We have the possibility to deal directly with the manufacturer/supplier, but if preferred contacts can run via the sponsor of the project. For on-site third party GMP-audits – presently required for all APIs – we have our own network of accredited auditors.

• Generic applications
• Updates of existing dossiers
• New full applications
• Detailed and Critical Summaries
• Acting as applicant or assistance before and during applications
• Monitoring and second opinion
• ASMF/CEP evaluation
• Laboratory services