Canada Health Authority Interactions

Elevate your Health Canada engagement strategy with Freyr's comprehensive interaction services. Our expertise spans pre-submission meetings, scientific advice requests, and strategic communications, paving the way for smoother drug approvals.

Canada Health Authority Interactions - Overview

Regulatory agency interactions are key in achieving a positive impact on the approval timelines and overall costs. Since the final decision on drug product approvals lies with Health Canada, it is important to ensure that the interactions with the Agency (whether face-to-face, in writing, or via teleconference) are conducted efficiently throughout the Regulatory process.

Sponsors can request Canada Health Authority interactions to understand the bioequivalence study design and other expectations for the content, format, and level of information required to be included in the pre-submission meetings. Health Canada provides generic applicants with an opportunity to discuss and clarify the expectations of the development plans and meetings to help applicants identify the potential risks and issues related to their ANDS applications so that the appropriate risk-mitigation strategies can be implemented to minimize the approval time.

Freyr, with expertise in handling end-to-end registration activities and Canada Health Authority interactions, can assist applicants in all types of formulations, Regulatory submissions, procedural guidance, and understanding the concerns along with the compilation of appropriate responses with scientific justification to avoid further queries.

Canada Health Authority Interactions - Expertise

  • Pre-submission communications with Health Canada (HC) to confirm the formulation of the drug product.
  • Preparation of meeting packages, documents, meeting plans, meeting minutes, and communication results in alignment with HC guidelines.
  • Requesting scientific advice from HC before the ANDS application submission.
  • Implementation of relevant meeting strategy that covers the overall objectives and fulfills the meeting’s goal.
  • Follow-up activities and post-meeting requirements like the submission of meeting minutes and development of program strategy based on Health Authority interactions.
  • Evaluate the queries and formulate appropriate responses to them.
  • Compilation of scientific justification in case of rejection of pre-submission meeting requests.
  • Correspondence with HC on day-to-day activities for clarifications on a submission strategy.
Canada Health Authority Interactions

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​