Health Canada ANDS

Our comprehensive Abbreviated New Drug Submission (ANDS) services offer streamlined and methodical assistance for generic drug approvals in Canada, ensuring compliance with Health Canada requirements. Our expertise spans from pre-submission consultations to post-submission support, optimizing the regulatory pathway for efficient market entry.

Health Canada ANDS - Overview

Abbreviated New Drug Submission (ANDS) is the application submitted to Health Canada for the review and approval of generic drugs against the Canadian Reference Product (CRP).

Following the review of the Health Canada ANDS, a Notice of Compliance (NOC) and Drug Identification Number (DIN) are issued, provided the information is sufficient to support the safety, efficacy, and quality of the drug for its commercialization in Canada. 

The drug registration process in Canada has similarities to those of the United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA). However, the unique procedural and specific technical requirements of Health Canada demand a Regulatory expert to handle the registration activities. A complete understanding of the typical procedural requirements like Drug Establishment License (DEL) and others are critical for quicker registration and approval.

Freyr has extensive experience in supporting clients with the preparation, review, and Abbreviated New Drug Submission (ANDS) pathways to Health Canada.

Health Canada ANDS - Expertise

  • Regulatory consultation during product development & manufacturing phase for selection of CRP, review of specifications for finished product/in-process controls/API, product development report, process validation protocol/report, stability study and batch size requirements.
  • Prepare/review of ANDS submission strategy and guidance on risk mitigation plans in line with Health Canada requirements.
  • Handling pre-submission meetings with Health Canada.
  • DEL application submission.
  • Providing checklist for Abbreviated New Drug Submission (ANDS) documents.
  • GAP analysis/Regulatory assessment of generated source data for Regulatory adequacy.
  • Guidance on the generation of additional/missing documents to comply with Health Canada. specific requirements.
  • Preparation of Abbreviated New Drug Submission (ANDS) package in line with current Health Canada requirements, publishing and submission in eCTD format.
  • Interaction/follow-ups with Health Canada for the ANDS approval.
  • Regulatory strategy and quick response preparation for HC queries.
  • Regulatory submission road map/filing procedure for ANDS and generating supporting documents.
Health Canada ANDS

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​