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 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



  • Manufacturing License
  • GMP Certificate – market products
  • GMP Certificate – clinical supplies