Lifecycle Management

 

Lifecycle Management - Overview

A Marketing Authorization Holder (MAH) is responsible for keeping the registered dossier up to date as per country-specific requirements for pharmaceutical product lifecycle management. Based on the concerned Health Authority requirements, the MAH should file an Annual Report (AR) or a Renewal Request on a periodic basis. Global Health Authorities have different requirements for filing annual reports or renewal submissions. In such scenarios, to get approval/acceptance at the earliest, a Regulatory submission strategy plays a significant role. Hence, manufacturers may consider specialized Regulatory consulting for CMC lifecycle management of the Regulatory submissions for already approved products.

Freyr, a leading player in centralized Chemistry, Manufacturing and Controls (CMC) and pharmaceutical product lifecycle management for Regulatory submissions, offers CMC Regulatory affairs consulting to global pharmaceutical companies.

Lifecycle Management

CMC Annual Report Submissions:

  • CMC lifecycle management by creating an Annual Report scheduler.
  • Provide CMC lifecycle management Regulatory strategy and timelines for the required documents.
  • Request a list of changes implemented in the reporting period along with CMC documentation.
  • Regulatory assessment of the supporting documents.
  • Request for additional documents/justification.
  • Authoring of the Annual Report package.
  • Finalization of the Annual Report package and submission in the eCTD format.
  • Updating the database with submission details and status.

Renewal Applications:

  • Tracking of the renewal application scheduler.
  • Provide CMC Regulatory strategy for documents required and timelines.
  • Sending the renewal initiation documents request to the manufacturer and requesting CMC documentation.
  • Regulatory assessment of the supporting documents for renewal application submission.
  • Request for additional documents/justification.
  • Authoring of renewal package in line with country-specific requirements.
  • Finalization of renewal dossier and submission to the Health Authority/Country Manager before the renewal application due date.
  • Update the database with submission details.
  • Expertise in Product Lifecycle Management (PLM) based on global Health Authority requirements.
  • Regulatory support in managing drug development lifecycle.
  • Specialized Chemistry Manufacturing and Controls consulting.
  • Designing tailormade Regulatory CMC strategies.

Streamline Your Pharmaceutical Product Lifecycle Management

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​