Health Canada Drug Master File (DMF) Submission

Trust Freyr for your critical Health Canada DMF submissions, blending Regulatory expertise with strategic planning. Our services span from initial filings to annual updates, ensuring efficient management of your drug master files in Canada.

Health Canada Drug Master File (DMF) Submission - Overview

The Health Canada Drug Master File (DMF) is a document submitted to Health Canada to provide important information about an Active Pharmaceutical Ingredient (API), finished dosage form, excipients & container closure systems, and processes used in the manufacturing, processing, packaging, and storing of human drugs. It is submitted to support the drug application. The Health Canada DMF submission is not mandatory. However, manufacturers can file the DMF to maintain the confidentiality of proprietary information for the holder.

The information submitted in the Health Canada drug master file can only be accessed by Health Canada if the file holder provides a Letter of Access (LOA) to the applicant and Health Canada. Additionally, the DMF holders can submit a copy of the Certificate of Suitability (CEP) for quicker review and acceptance of the master file.

Freyr has a Regulatory team with an in-depth understanding and experience in handling the Health Canada drug master file registration activities in the eCTD format, along with managing and updating the MFs in alignment with the latest guidelines.

Health Canada Drug Master File (DMF) Submission - Expertise

  • Serve as an agent between the Agency and the manufacturer for interactions with Health Canada.
  • Regulatory submission strategy for different types of Master Files (MFs) for drug substance (Type I), packaging materials (Type II), and Excipients (Type III).
  • Guidance on selection of Regulatory starting material and route of synthesis for drug substance in line with HC expectations.
  • Support in designing the limits for impurities in starting materials, intermediates, and their carry-over to APIs.
  • Designing of specifications for starting materials, in-process, intermediates, and drug substance.
  • Support in setting the strategy and limits for genotoxic impurities and elemental impurities in intermediates or drug substance.
  • Guidance on designing the protocols for stability studies, process validation, hold time study, and forced degradation studies for MF submission.
  • Preparation and submission of Type I/II/III Master Files in line with Health Canada requirements.
  • Publishing of MFs in the eCTD format as per the current HC guidelines and requirements.
  • Change control evaluation and Regulatory strategy, preparation and submission of amendments, and annual reports for already registered Master Files.
  • Regulatory strategy, preparation, and submission of responses to Health Authority queries.
  • Conversion of existing paper/non-CTD MFs into the eCTD format.
Health Canada Drug Master File (DMF) Submission

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​