Due Diligence Assessment of ANDA

Freyr offers comprehensive due diligence assessment services for generic drug products, ensuring compliance with Health Authority requirements. Our expertise covers Regulatory strategy, gap analysis, and risk mitigation, supporting clients from drug development through ANDA approval.

Due Diligence Assessment of ANDA - Overview

Due diligence assessment involves a detailed review of the existing data, Regulatory strategy, and study plans for the generic drug product per the Health Authority (HA) requirements. Following a proper process can help minimize future risks or hurdles, from the drug development stage to the Abbreviated New Drug Application (ANDA) approval.

Freyr provides Regulatory support in US FDA due diligence services like due diligence of branded generic pharmaceuticals for all HA submissions, along with the development of ANDA submission strategies and risk-mitigation plans to avoid any potential compliance risks throughout the product’s lifecycle.

Due Diligence Assessment of ANDA - Expertise

  • Regulatory consultation and pre-submission support for a generic drug application.
  • Regulatory assessment of dossiers against the US FDA requirements.
  • Gap analysis of the ANDA to identify the potential gaps and anticipated queries from the US FDA.
  • Ensuring compliance with the RTR standards.
  • Mitigation strategies for the gaps identified through FDA due diligence in the draft ANDA.
  • Preparation of effective strategies for the HA submissions as per the Regulatory requirements.
  • Regulatory expertise in on-time communication or interactions with the HA so sponsors understand the HA queries better.
Due Diligence Assessment of ANDA

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​