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GMP and Applicant service
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, §73 AMG certificates)
- in cooperation with the authority of Berlin (LAGeSo)
- GDP / GMP consulting for pharmaceutical entrepreneurs 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)
Authorizations
- Manufacturing License
- GMP Certificate – market products
- GMP Certificate – clinical supplies