Post-approval Changes to Drug Substance

Elevate your post-approval change strategy with Freyr's specialized Regulatory services for medicinal drug products/ substances. Our team offers tailored support for all variation types, ensuring compliance, minimizing delays, and optimizing the entire change management process.

Post-approval Changes to Drug Substance - Overview

Post-approval changes to drug substances can arise throughout the lifecycle of a drug product and must be addressed appropriately. After the approval and during its commercialization, manufacturers may propose certain changes to a product and/or the active substance for optimizing operational costs, increasing productivity, administrative reasons, etc.

Evaluation of such changes must determine whether a submission to the relevant Health Authorities (HAs) is necessary, and if it is, a variation package must be prepared. The submission required might be a Type IA, IA, IB, or Type II variation package, depending on the categorization of the change following the relevant variation guidelines.

Changes requiring HA approval must only be implemented after it has been granted, and in many cases, the implementation may be done within a defined period following the approval. Robust post-approval submission strategies and accurate change categorization are critical to minimize HA questions and rejections.

In order to maintain compliance, timely submission of changes is essential during the lifecycle of drug products. Freyr’s Regulatory affairs team has extensive experience in handling CMC post-approval changes and the required submissions to European HAs in alignment with the relevant requirements and guidelines.

Post-approval Changes to Drug Substance - Expertise

  • Change addition/deletion in the manufacturing site.
  • Support in MAH transfers.
  • Change in the formulation and batch size.
  • Optimization of manufacturing process/change in route of synthesis/change in equipment.
  • Addition/change of active substance supplier/CEP updates/new CEP.
  • An additional source for active substance starting material.
  • Pharmacopoeia monograph updates.
  • Specifications and analytical method changes.
  • Changes in container closure systems and suppliers.
  • Shelf-life extension/reduction.
  • Administrative updates/changes in contact details.
  • Offering support in post-approval changes to generic drug substances.

Additionally, Freyr offers the following services to medicinal product manufacturers:

  • Change control support and change evaluation.
  • Consultation on submission strategy for proposed changes.
  • Implementation of strategy and timelines.
  • Guidance on supporting documents/data.
  • Preparation of variation submission documentation.
  • HA interactions for approval and implementation.
  • CMC Regulatory compliance of legacy dossiers and submissions.
Post-approval Changes to Drug Substance

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​