Abbreviated New Drug Submission

 

Abbreviated New Drug Submission - Overview

Registration of pharmaceutical products with Health Canada through the Abbreviated New Drug Submission (ANDS) application might have similar technical requirements to that of the United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA). This simplifies the Canadian registration process for medicinal products which are already registered with the U.S. and the EU Health Authorities. However, to understand Health Canada’s unique procedural and technical requirements like, Drug Establishment License (DEL), it is vital to consult a Regulatory expert for quicker registration and approvals.

Freyr has prior experience and expertise in handling generic application (ANDS) submissions with Health Canada for all kinds of dosage forms of pharmaceutical products. Freyr plays a key role in streamlining the registration and approval procedures and is capable of:

Abbreviated New Drug Submission - Expertise

  • Regulatory submission road map/filing procedure for ANDS and supporting document generation.
  • Regulatory consultation during product development & manufacturing phase for selection of RLD/Reference Standard, review of specifications for finished product/in-process controls/API, Product Development Report, process validation protocol/report, stability study, and guidance on batch size requirements.
  • Preparation/review of the ANDS Health Canada submission strategy and guidance on risk mitigation plans.
  • Handling pre-submission meetings with Health Canada.
  • Support for DEL application submission.
  • Providing ANDS documents checklist.
  • Gap-analysis/Regulatory assessment of generated source data for Regulatory adequacy.
  • Guidance on the generation of additional/missing documents.
  • Preparing Abbreviated New Drug Submission package in line with the current Health Canada requirements.
  • Publishing and submission of the ANDS in the eCTD format.
  • Interaction/follow-ups with Health Canada for the ANDS approval.
  • Regulatory strategy and response preparation for HC queries for quicker approvals.
Abbreviated New Drug 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​