Biologics Registration Services

 

Biologics Registration Services - Overview

Biological products are complex medicinal products and include a wide range of subcategories such as recombinant therapeutic proteins, monoclonal antibodies, cellular & gene therapy products, vaccines, blood & blood components, etc. The Regulatory requirements for biological products are vast and vary based on the type of product. Similarly, a separate set of Regulatory frameworks is being laid down for subsequent entry biologics, which are globally recognized as biosimilar products. A biologics registration services provider helps in understanding the Regulatory framework and evaluating the requirements of each subcategory of a biological product in the emerging markets (RoW countries), which is challenging and demands complete knowledge of the product and country-specific Regulatory information. A biologics registration services provider can help ease this challenging Regulatory process.

When compared to major markets (e.g., US, EU, Japan, and Australia), assessing the Regulatory requirements of the RoW market (Asia, Africa, Latin America, GCC, & CIS regions) is more complicated due to the diverged Regulatory approach followed by different Health Authorities. Differences in the Regulatory requirements for each type of biological/biosimilar product and ever-evolving submission requirements of RoW Health Authorities make the registration and approval process more challenging. To overcome the hurdles and achieve successful submission in RoW markets, biologics registration services and strategy support from a proven Regulatory affairs partner is of utmost importance.

Freyr is a niche Regulatory service provider with significant experience in handling novel biologics, biosimilars, vaccines, blood & plasma products, and cellular & gene therapy products across the RoW countries. Our team at Freyr can provide you with complete guidance on Regulatory strategy and biologics registration services.

Biologics Registration Services - Expertise

  • Freyr has a good pool of industry and ex-agency experts with more than 25 years’ experience in the biologics/biosimilars Regulatory space.
  • Freyr teams have excellent technical and scientific competencies to handle Regulatory issues associated with different Recombinant Expression Systems (E.coli, Yeast, rCHO cells etc.) and different types of mammalian cell lines (Vero cells, MRC-5 cells, SPF CEF, etc.).
  • Successful track-record in handling Combination Products that are a combination of a biological product and a device (PFS, Pen injector, etc.).
  • Regulatory strategy for global expansion of biological products/biosimilars. This includes strategic planning for clinical trials in specific regions, stepwise approach for product registration in multiple countries, strategic approach in Regulatory submissions, and HA query responses.
  • Drug development strategy for biosimilars. This includes identification of reference medicinal product, demonstration of analytical similarity, clinical data waivers, reducing the need for clinical data generation on local population, etc.
  • Regulatory strategy/Regulatory insight reports for entry into new RoW countries.
  • Setting up agency meetings and representing the sponsors to resolve scientific matters during the product registration.
  • Biological product registration in all RoW markets (Asia, Africa, LATAM, GCC, & CIS).
  • Country-specific Regulatory gap assessment for registration of intended biological product/ biosimilar product.
  • Core dossier redaction/dossier preparation in country-specific formats, necessary support for translation of dossier into the local language and Regulatory submissions management.
  • Submission support for biological products CMC variations/amendments/supplements to different Health Authorities.
  • Biological product lifecycle management and renewals.
Biologics Registration Services- Rest of the World Market

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​