Gap Analysis and Authoring

Trust Freyr for critical ANDA gap analysis and CTD authoring services, blending Regulatory expertise with strategic planning. Our comprehensive approach ensures compliance, minimizes FDA queries, and streamlines the path to generic drug approvals.

Gap Analysis and Authoring - Overview

Thorough Regulatory assessment/gap analysis of the source documents/data and the first-time-right quality authoring of CTD sections for an ANDA application are very vital to clear the RTR screening and also receive the approval in the first review cycle on the goal date, which allows the manufacturer/ANDA holder to market the generic drug in the USA region without delay.

Gap analysis of all source documents/data/study reports helps in identifying the gaps in the ANDA content and can allow to building of the mitigation plan and strategy to provide logical and scientific justifications to avoid major queries from the USFDA subsequently to receive approval on time.

Freyr, with a highly skilled cross-functional team and expertise in Regulatory submissions, can assist applicants in determining the HA requirements and perform comprehensive ANDA gap analysis and authoring of source documents/data.

Gap Analysis and Authoring - Expertise

  • Regulatory Assessment/Gap analysis of the source documents/data for adequacy as per the USFDA requirements
  • Sharing of identified gaps Providing the necessary mitigation strategy for identified gaps
  • Experienced resources with previous experience in R&D, quality and analytical departments for an in-depth review of the documents/data
  • Review of the documents/data/reports for their compliance with Refuse-To-Receive (RTR) standards
  • Implementation of best practices/guidance/queries with previous submission to the USFDA in ANDA gap analysis and authoring
  • Authoring of CTD sections using the CTD templates as per the USFDA’s ANDA requirements for content and format
  • Authoring of CTD sections for supplements/amendments/annual reports to the registered applications as per the USFDA expectations
  • Assessment of the Regulatory submission strategy
  • Review of the qualitative and quantitative composition of the medicinal product for acceptability
  • Impurities limits as per the ICH requirements based on MDD
  • Gap analysis of the protocols/reports for product development, process validation, stability program, exhibit batches, batch size for registration, hold time study
  • Dissolution method/parameters selection
  • Biowaiver criteria
  • Health Authority mandatory requirements
  • Gap analysis of draft CTD package to ensure the adequacy for submissions like ANDAs/DMFs
  • Gap analysis of the supplement submission strategy and suggestions
Gap Analysis and Authoring

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​