Abbreviated New Drug Application Submissions

 

Abbreviated New Drug Application Submissions - Overview

In the realm of pharmaceuticals, an Abbreviated New Drug Application (ANDA) is the gateway for generic medicinal products to establish their therapeutic equivalence to innovator/branded drugs in terms of quality, safety, and efficacy, offering a cost-effective alternative. The United States, recognizing the potential of the generic medicines market actively promotes the expansion of generic manufacturers by encouraging them to register their generics through the ANDA filing process using the 505(j) route of the ANDA filing process.

The ANDA filing process and ANDA Regulatory approval is a crucial step in the generic drug approval. However, considering the US FDA’s ever-evolving ANDA submission requirements, it is challenging for manufacturers to decode the guidelines and adhere to specific requirements such as product development by QbD approach, Module 2 in QBR format, and the GDUFA program implementation. Due to this, it has become necessary for manufacturers to involve Regulatory Affairs experts from the initial product development stage for timely registration, quicker approval, life cycle management, and the ANDA filing process.

Freyr is a trustworthy Regulatory partner for cost-effective, RTR (Refuse-to-Receive) compliant, and on-time submissions and approvals. Freyr can play a key role in speeding up the US FDA review process for an ANDA approval. With a clear-cut understanding of the ANDA submissions requirements and a holistic risk management approach, Freyr helps you explore the shortest route and timeframe to put your products on the market safely, aiming at ultimate commercial success. With regards to ANDA services Freyr’s capabilities include the following:

Abbreviated New Drug Application Submissions - Expertise

  • Strategic support for ANDA submission roadmaps/ANDA filing process and supporting document generation for ANDA submission Process.
  • Regulatory consultation during product development & manufacturing phase for selection of RLD/Reference Standard, review of specifications for APIs/in-process controls/finished product, product development report using QbD principles, process validation protocol/report, stability study, compliance to IIG database, Q1/Q2 compliance for parenteral, otics, & ophthalmic, and guidance on batch size requirements.
  • Preparation/review of ANDA submission strategy and guidance on risk mitigation plans.
  • Pre-submission FDA interactions and walkthrough support in control correspondences.
  • Pre-submission administrative activities like facility identification, request for DUNS/FEI/ANDA Application numbers, etc.
  • Sharing of Abbreviated New Drug Application (ANDA) documents checklist.
  • Gap analysis/Regulatory assessment of generated source data for Regulatory adequacy.
  • Guidance on the generation of additional/missing documents for Refuse to Receive (RTR)/GDUFA compliance.
  • SPL submission for facility establishment, drug listing, and renewals.
  • Compilation of quality ANDA package as per the current FDA and RTR requirements, publishing, and submission in the eCTD format via the FDA ESG.
  • Interaction/follow-ups with the US FDA for the ANDA Regulatory approval process.
  • Support in resolving critical RTR (Refuse-to-Receive) issues.
  • Regulatory strategy and response preparation for queries (IRs/DRL/CRLs) during the ANDA approval process.
Abbreviated New Drug Application 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​