Change Control Assessment and Change Submission Strategy

Empower your ANDA/DMF change management process with Freyr's comprehensive assessment and submission strategy services. We offer expert guidance from initial impact evaluation to final Regulatory documentation preparation.

Change Control Assessment and Change Submission Strategy - Overview

Changes with the potential to impact the content of the CTD require a thorough assessment to determine the appropriate course of action. The change control impact assessment of ANDA/DMF must include a full understanding of the change, and visibility of all impacted products (i.e., finished products and APIs) and must determine all countries where those products are registered. This might also include countries where a new product submission or approval is pending.

As registered details for a product can differ between countries, it is essential to review all amendments of the relevant registered information so that a complete change control impact assessment can be performed considering the regulations and guidelines applicable in the intended country (i.e. the US) where the product is approved. The change control impact assessment will determine the classification of the change and the required supporting documentation. 

A robust change control assessment of the product is critical in developing a suitable DMF/ANDA change submission strategy and ensuring continued product compliance. Freyr’s Regulatory Affairs team has extensive knowledge and experience in change control assessment, post-approval submission strategy, and preparation of change-related submission packages as per the Health Authority requirements and guidelines.

Change Control Assessment and Change Submission Strategy - Expertise

  • Evaluation of change control and supporting documents as per the USFDA guidelines
  • Preparation of a post-approval submission strategy for the proposed change
  • Providing the list of supporting documents/data to be included/generated
  • Guidance on the implementation strategy for the proposed change
  • Preparation of supporting Regulatory documentation (e.g., revised Module 3 sections, Module 1 documentation) for finished products and APIs
Change Control Assessment and Change Submission Strategy

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​