Certification of Suitability

 

Certification of Suitability - Overview

Filing Active Pharmaceutical Ingredient (API) information with the European Directorate (ED) for the Quality of Medicines and HealthCare (EDQM) is not mandatory. However, possessing a Certification of Suitability (CEP) is an added advantage for API manufacturers while entering the EU. CEP to the monographs of the European Pharmacopoeia can be filed only for APIs which have monographs in the European Pharmacopoeia (Ph. Eur).

Most of the emerging markets like Australia, Canada, and all the EU countries accept CEP instead of the Active Substance Master File (ASMF)/Drug Master File (DMF) submissions. Letter of Access (LoA) of CEP received from the EDQM can be provided to drug product applications like MAA to all the EU countries, Therapeutic Goods Administration (TGA) of Australia, and the Abbreviated New Drug Submission (ANDS) to Health Canada (HC) instead of the ASMF/DMF submission.

EDQM has specific requirements for the submission and granting of CEP for API/drug substances. Hence, expertise is required in filing CEPs with EDQM for quick approval of MAAs/ANDS.

Freyr has a strong Regulatory team with expertise in compilation, review, and submission of CEP to EDQM in line with the EDQM guidelines. With a strong footprint in handling CEP submissions to EDQM for all types of APIs (manufactured by chemical/fermentation/sterile), Freyr is proven to be a preferred Regulatory partner for API manufacturers.

Certification of Suitability - Expertise

  • Identifying the Regulatory starting material and route of synthesis for APIs/drug substances.
  • Specification designing for starting materials, raw materials, excipients, packing materials, in-process, intermediates, and drug substances.
  • Setting the strategy and limits for genotoxic and elemental impurities.
  • Finalization of stability protocol, process validation protocol, hold time study protocol, degradation study protocol and analytical method validation protocol, and provide review support for the respective reports for submission.
  • Gap-analysis of source documents/data generated for CEP submission in line with the current EDQM requirements/guidelines.
  • Compilation, review, and submission of CEP in line with the EDQM requirements for APIs.
  • Publishing of CEP in eCTD/NeeS/PDF as per the EDQM guidelines.
  • Evaluation of change controls for Post-Approval Changes (PAC).
  • Regulatory assessment of PAC and preparation of variation submission strategy.
  • Compilation, review, and submission of Variations (Type IA/Type IAIN/Type IB/Type II) to CEPs for PAC in line with the EDQM variation guidelines.
  • Compilation, review, and submission of renewals for CEPs to maintain the lifecycle and validity of the granted CEP.
  • Preparation of Regulatory strategy and response to Health Authority queries (RTQs) for quick approval of CEPs.
Certification of Suitability

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​