Regulatory Compliance and Gap Analysis

Freyr, a trusted Regulatory partner, offers expert Regulatory gap analysis to ensure compliance and minimize submission rejections, providing manufacturers with strategic insights for successful medicinal product registrations.

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Regulatory Compliance and Gap Analysis - Overview

Regulatory compliance and gap analysis of the supporting documents/data are critical for registering medicinal products. Though most Health Authorities (HAs) accept applications/dossiers in the CTD format, the content to be provided in the CTD section may vary. Thus, a thorough Regulatory gap analysis/technical assessment of the documents/data enables manufacturers to identify and mitigate the gaps before the submission. It avoids submission rejections and minimizes any major/critical queries to hasten the approvals.

Gap analysis of the legacy dossiers against the current practices followed for the medicinal product’s manufacture ensures Regulatory compliance. The identified gaps can be mitigated by the submission of probable supplements/variations to avoid non-compliance. Freyr, as a proven service provider with experienced Regulatory Affairs CMC resources, provides Regulatory gap analysis support.

Regulatory Compliance and Gap Analysis - Expertise

  • Assessment of the Regulatory submission strategy.
  • Gap analysis of the supporting documents/data generated during the development stage of the medicinal product.
  • Review of the qualitative and quantitative compositions of the medicinal product for acceptability.
  • Ensure the impurity limits are in line with the ICH requirements based on the Maximum Daily Dosage (MDD).
  • Regulatory gap analysis of the protocols/reports for product development, process validation, stability program, exhibit batches, batch size for registration, and hold-time study.
  • Dissolution method/parameters selection.
  • Biowaiver criteria.
  • Assessment of the existing dossier for market expansion.
  • Region-specific stability study requirements.
  • Regulatory compliance requirements.
  • Gap analysis of the draft CTD package to ensure the adequacy for submissions like INDs/IMPDs/CTAs/NDAs/MAAs/DMFs/Dossiers.
  • Technical review of change controls.
  • Regulatory gap analysis of the variation/supplement submission strategy and suggestions.

Partnering with Leading Organizations

 

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

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

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​