Hybrid Applications

Mastering Hybrid MAAs is crucial for modified generic products in Europe. Freyr offers specialized Article 10(3) submission services, encompassing bridging studies, Regulatory strategy, and Health Authority liaison to optimize your approval process.

Hybrid Applications - Overview

Registration of the Marketing Authorization Application (MAA) for a generic product with changes in active substance(s), therapeutic indications, strength, and route of administration compared to the reference medicinal product is very complex as the MAA relies on pre-clinical and clinical trial data concerning the reference product and new data. In such a scenario, bridging studies are critical to show the equivalency with the reference medicinal product for on-time registration and receipt of approval for hybrid application through Article 10(3) from EMA/EU Health Authorities.

Freyr, with wide experience in handling MAA submissions for hybrid applications (Article 10(3)), acts as a cost-effective and trust-worthy Regulatory partner to pharmaceutical manufacturers/Marketing Authorization Holders (MAHs) in order to handle all legal and administrative requirements, along with registration activities, for the medicinal products.

Hybrid Applications - Expertise

  • Preparation and review of study designs to be performed for bridging studies
  • Pre-submission meetings with the EMA or with other EU Health Authorities
  • Preparation and support of submission packages for scientific meetings with the EMA/EU Health Authorities
  • Regulatory submission road map/way forward for generic and hybrid applications
  • Selection of dissolution parameters/multimedia for performance of dissolution for test product and RMP
  • Support in the preparation of product development report (discriminatory nature of media)
  • Finalizing the specifications for finished products, in-process/intermediates and review of protocols/reports for exhibit batches/stability study
  • Assistance in selection of Regulatory submission procedure i.e. Centralized Procedure (CP), National Procedure (NP), Decentralized Procedure (DCP) or Mutual Recognition Procedure (MRP)
  • Slot booking for MAA submissions
  • Liaise with country HA to act as RMS for MAA filing in DCP
  • Technical gap analysis of source documents/data for adequacy against EU countries specific requirements
  • Compilation, technical review, finalization, publishing and MAA submissions in eCTD format
  • Regular follow-ups with Health Authorities
  • Handling Health Authority (HA) queries with strategies and preparation of response package for submission for marketing authorization approval
  • Translation support during the national phase of the registration in all EU languages
Hybrid Applications

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​