EDQM Preparation & API CEP/ DMF Services

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EDQM Preparation & API CEP/ DMF Services:

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 provides complete support for Inspection preparedness, overseeing the actual inspection and facilitating the same, verification of technical observations with inspectors and query response.

Additionally we provide complete services for API Regulatory.

CEP

Regulatory Strategy and Advice
- Suggestion pertaining to API development and technical queries.
- Regulation for technical and administrative requirements for CEP filing.
- Roadmap for approval, fees, timeframe.
Scientific Review of dossier & Gap Analysis of technical data
- Evaluation of technical data pertaining for Drug Substance impurities, residual solvents, development report, batch manufacturing and packaging records; Highlighting discrepancies in the technical documentation to the company along with proposed solution.

Scientific writing of CEP
- Module 1: Cover Letter, application form and expert information writing and verifying.
- Module 2: Quality Overall Summary
- Module 3: Scientific writing of m1, m2, and 3 based on accurate technical data provided by the company.
Submission to authority through online platform.
Support on Query Response from Agency:
- Post submission, review of queries, support documentation and drafting of response for
  ASMF (EU member states) further submission.

ASMF (EU Member States) and USDMF

ASMF (EU Member States)

Scientific writing support for Applicant part (AP) and Restricted Part (RP) of ASMF
ASMF Submission to each EU member states
Query response
ASMF acceptance

USDMF

Development advice for Pharmacopoeia and internal quality active substance DM
Writing in CTD & submission in eCTD to CDER, FDA
Deficiency response for complete assessment review of DMF
Maintaining Active status of DMF
Support in major change update

Master File Submission (API) - Case Study

Read how we imparted in technical review of ASMF

Download Case Study