Change Control Evaluation and Variation Submission Strategies

Freyr offers specialized change control evaluation and variation submission services, providing end-to-end support from impact analysis to Health Authority interactions for generic medicine changes.

Change Control Evaluation and Variation Submission Strategies - Overview

Changes with the potential to impact Module 3 of the CTD require a careful and thorough assessment to determine the appropriate course of action. The change control evaluation of MAA 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 variants of the relevant registered information so that a complete change control impact assessment can be performed considering the European countries regulations and guidelines. The assessment will determine the classification of the change and the required supporting documentation. Strategies for submission of change applications can be impacted by many factors, including expected approval timelines and the data requirements for submission.

A robust change control impact assessment of generic medicines is critical in developing a suitable MAA change submission strategy, and for ensuring continued product compliance. Freyr’s CMC Regulatory Affairs team has extensive knowledge and experience in pharma change control assessment/change control impact assessment, preparation of change-related submission packages, and developing generic medicine change submission strategies in alignment with Health Authority requirements and guidelines.

Change Control Evaluation and Variation Submission Strategies - Expertise

  • Pharma change control impact assessment for all dosage forms in all countries in accordance with relevant regulations and guidelines
  • Preparation of a relevant MAA change submission strategy
  • Preparation of supporting Regulatory documentation (e.g., revised Module 3 sections, Module 1 documentation) and compilation of submission packages for finished products and APIs
  • Regulatory consulting on generic medicine change submission strategy of proposed changes
  • Managing Health Authority interactions (submissions, HA questions)
Change Control Evaluation and Variation Submission Strategies

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​