Health Canada ANDS, Abbreviated New Drug Submission (ANDS) Pathway

Health Canada ANDS

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 - Freyr Expertise

01
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.
02
Prepare/review of ANDS submission strategy and guidance on risk mitigation plans in line with Health Canada requirements.
03
Handling pre-submission meetings with Health Canada.
04
DEL application submission.
05
Providing checklist for Abbreviated New Drug Submission (ANDS) documents.
06
GAP analysis/Regulatory assessment of generated source data for Regulatory adequacy.
07
Guidance on the generation of additional/missing documents to comply with Health Canada. specific requirements.
08
Preparation of Abbreviated New Drug Submission (ANDS) package in line with current Health Canada requirements, publishing and submission in eCTD format.
09
Interaction/follow-ups with Health Canada for the ANDS approval.
10
Regulatory strategy and quick response preparation for HC queries.
11
Regulatory submission road map/filing procedure for ANDS and generating supporting documents.

What our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is 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 look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company

Health Canada ANDS

Health Canada ANDS - Overview

Health Canada ANDS - Freyr Expertise

Regionwide Expertise

What our Clients Say?

President

Quality Control and Regulatory Manager

Senior Research Assistant,

Operations Head,

System Owner,

Graphics Manager | Global Regulatory Affairs,

Get in Touch

USA

UK

GERMANY

INDIA

More Locations

Quick Inquiry

Health Canada ANDS

Health Canada ANDS - Overview

Health Canada ANDS - Freyr Expertise

Regionwide Expertise

What our Clients Say?

President

Quality Control and Regulatory Manager

Senior Research Assistant,

Operations Head,

System Owner,

Graphics Manager | Global Regulatory Affairs,

Subscribe to Our Newsletter

Get in Touch

USA

UK

GERMANY

INDIA

More Locations

Quick Inquiry