Regulatory Affairs Services

Preparation of GMP Audit Application Dossiers

Preparation of GMP Audit Application Dossiers

Our team shall prepare GMP application dossiers for overseas GMP audits of all stages of manufacturing subject to inspection under the “Guidelines on Applications for GMP Audits of Overseas Manufacturing Sites” published on the official website of the Turkish Medicines and Medical Devices Agency and updated on 02.07.2018.

  • Determining missing documents for the GMP Application Dossier (Gap Analysis)
  • Preparation of On-Site GMP Audit Applications
  • Preparation of Risk-based Audit Applications
  • Preparation of On-File Audit Applications
  • Preparation of responses for missing/incomplete information or documents