Abbreviated New Drug Application

Accelerate your generic drug approval process with Freyr's expert ANDA submission services. From Regulatory roadmaps to post-submission support, we provide comprehensive guidance to ensure compliance and minimize delays in bringing your product to market.

Abbreviated New Drug Application - Overview

The Abbreviated New Drug Application (ANDA) is an application submitted to the United States Food and Drug Administration (US FDA) for the review and approval of a generic drug demonstrating bioequivalence against an already-approved innovator drug so that the generic drug can be used as a safe, effective, and low-cost alternative to the brand-name drugs.

Applicants must file the ANDA submissions based on the content and format, Refuse-to-Receive (RTR) standards, and other US FDA guidelines, particularly the 505(j), for successful ANDA approval during the first review cycle.

Freyr, with extensive experience in registration activities for Abbreviated New Drug Applications, offers end-to-end ANDA submission services for manufacturers/sponsors and, thus, is a preferred Regulatory partner to ensure Market Authorization Application (MAA) approval right the first time.

Abbreviated New Drug Application - Expertise

  • Preparation of Regulatory roadmap strategy for ANDA filing.
  • Regulatory consultation during the drug development stage in the selection of the Reference Listed Drugs (RLDs), evaluation of excipients against the IIG database for oral drugs, and controlled correspondence submission for Q1/Q2 sameness for sterile products.
  • Review of quality-by-design protocols and reports and guidance on stability and bioequivalence studies for ANDA submission.
  • Support in pre-ANDA-submission administrative activities like a request for the ANDA number, Data Universal Numbering System (DUNS) number, the FDA Establishment Identifier (FEI) number, labeler code, etc.
  • Pre-submission FDA interactions and walkthrough support in control correspondences.
  • Gap analysis/Regulatory assessment of generated source data for Regulatory adequacy.
  • Compilation of the quality dossier per the current FDA and RTR requirements, publishing, and ANDA submission via the FDA Electronic Submission Gateway (ESG).
  • Preparation of strategic risk mitigation plans for error-free ANDA submissions to ensure zero RTR.
  • Regulatory response strategy and preparation for the response with scientific justifications for Health Authority queries (IRs/DRL/CRLs) during the ANDA filing process.
  • Critical support in resolving RTR issues for streamlined Abbreviated New Drug Application processes.
Abbreviated New Drug Application

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​