Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) establishes and provides official standards for the manufacture and quality control of medicines in all the signatory states of the ‘Convention on the Elaboration of a European Pharmacopoeia’ (an international treaty adopted by the Council of Europe).
As part of the quality evaluation programme for active ingredients and excipients used in the manufacture of medicines, the EDQM also runs an inspection programme for CEP (Certificate of Suitability) holders, targeting their manufacturing and/or distribution sites. A CEP applicant must also agree to comply with the relevant EU Good Manufacturing Practice guidelines and to accept an on-site inspection at any time at the request of the EDQM.
Metina offers strategic regulatory support to pharmaceutical manufacturers for Certificate of Suitability (CEP) and Active Substance Master File (ASMF) submissions, ensuring complete compliance with EU requirements and efficient regulatory navigation.
Authoring of complete CEP dossier including:
Module 1
Preparation of region-specific administrative documents including the application form, cover letter, and expert declarations, ensuring completeness and regulatory accuracy for CEP, ASMF, or DMF submissions.
Module 2
A well-structured Quality Overall Summary (QOS) capturing critical scientific and manufacturing data from Module 3, written in alignment with ICH guidelines for clarity and regulatory compliance.
Module 3
Comprehensive compilation and scientific write-up of all drug substance quality data, including manufacturing process, impurity profile, specifications, and stability, based on validated technical inputs provided by the sponsor.
Metina offers strategic regulatory support to pharmaceutical manufacturers for Certificate of Suitability (CEP) and Active Substance Master File (ASMF) submissions, ensuring complete compliance with EU requirements and efficient regulatory navigation.
Authoring of complete CEP dossier including:
Module 1
Preparation of region-specific administrative documents including the application form, cover letter, and expert declarations, ensuring completeness and regulatory accuracy for CEP, ASMF, or DMF submissions.
Module 2
A well-structured Quality Overall Summary (QOS) capturing critical scientific and manufacturing data from Module 3, written in alignment with ICH guidelines for clarity and regulatory compliance.
Module 3
Comprehensive compilation and scientific write-up of all drug substance quality data, including manufacturing process, impurity profile, specifications, and stability, based on validated technical inputs provided by the sponsor.
