Health Canada Query Management

Our Freyr's comprehensive query management expertise spans from action plan development to scientific justification preparation, ensuring swift and effective resolution of regulatory inquiries.

Health Canada Query Management - Overview

Health Canada can send requests like Screening Deficiency, Clarifax, and Notice of Non-compliance to the applicants for additional information/clarification on the content that has been submitted in the ANDS/DIN Application/MF, so that the technical review shall be completed and approved shall be provided. Response to the HC deficiency letters should be submitted on time with sufficient data with suitable scientific justifications to receive the approval within short timelines.

Inadequate response with incomplete supporting documents and lack of scientific justification may lead to another set of queries, which will delay the approval of the product. Hence, it is very important for the applicants to adequately respond to HC queries in short timelines. Freyr, with strong expertise in generics registration activities, can provide complete support in Health Canada query management along with the submission of complete responses to HC.

Health Canada Query Management - Expertise

  • Thorough review of the deficiencies received from HC against registered content
  • Preparation of an action plan
  • Preparation of response strategy and guidance to the applicant on activities to be performed
  • Assessment of additional data and or inputs received from ANDS applicants and identifying the gaps
  • Preparation and submission of a response package with scientific justifications and supporting documents
  • Correspondence with HC/Guidance for extension request and negotiation on the strategy (if necessary)
Health Canada Query Management

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​