Pre-ANDA Submissions

Accelerate your generic drug approval process with Freyr's pre-ANDA submission expertise. Our services range from offering strategic guidance to optimizing your ANDA preparation and submission.

Pre-ANDA Submissions - Overview

Pre-ANDA submission is a formal written request for feedback from the US FDA to assist applicants with generics application preparation. Before submitting a generic application for complex generic drug products, manufacturers may require a pre-ANDA meeting with the US FDA to get clarity in developing a complete ANDA application, set the Regulatory expectations in the early product development stage, and reduce the number of review cycles to obtain the ANDA approval.

Additionally, pre-ANDA submission includes requesting a facility self-identification that enables fast, accurate, and reliable inspection of generic drugs globally and facilitates compliance with the Regulatory standards. Before filing a request for a pre-submission meeting, the applicant must choose the correct pathway (product development, pre-submission, or controlled correspondence), provide enough information, and follow the guidance on ANDA meetings with the US FDA.

The Agency has different criteria and timelines to accept the applicant’s request for pre-ANDA submission meetings. Freyr has been assisting its clients with various pre-submission meetings and other administrative activities during and post the meetings for effective ANDA assessment. Our Regulatory experts help clients understand the exact HA requirements and prepare and submit the pre-ANDA meeting packages within the proposed timeframe through the US FDA electronic gateway.

Pre-ANDA Submissions - Expertise

  • Submit a pre-ANDA meeting request to the USFDA.
  • Preparation of a suitable Regulatory strategy (product development, pre-submission, or controlled correspondence) before filing a pre-ANDA submission request.
  • Requesting scientific advice from Regulatory authorities before ANDA submission for complex products.
  • Compilation of scientific justification in case of a rejection of the pre-submission meeting request.
  • Evaluation and preparation of Regulatory response action plan.
Pre-ANDA Submissions

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​