GMP service
- Auditing of manufacturer of active pharmaceutical ingredients (API)
– issuing of QP declaration(s) - Auditing of manufacturer of medicinal products
- GMP consulting for the application of EU GMP inspections with the purpose of marketing of medicinal products in the EU (§72a AMG certificates)
– in cooperation with the authority of Berlin (LAGeSo) - GDP / GMP consulting for pharmaceutical enterpreneurs and wholesalers
– in cooperation with the local authority, e.g. LAGeSo
Applicant for marketing authorization
- SME status is already granted
- Updating or issuing of the Site Master File for Pharmacovigilance and preparation of related CTD documents
- Qualified Person for Pharmacovigilance (QPPV)
- Submission of the registration dossier
Authorizations
- Manufacturing License
- GMP Certificate – market products
- GMP Certificate – clinical supplies