Biologics License Application, BLA submission, 351(a), 351(k)

Biologics License Application (BLA)

With the evolving Regulatory enforcement for advanced therapies such as cellular and gene therapy products and other complex biologics/biosimilars that require extensive evaluation of the quality, safety, and efficacy aspects of drug products, Health Authorities have started implementing risk-based review procedures for Biologics License Applications (BLAs) approval. As a result, there might be chances of missing out on mandatory information in the BLAs that could lead to a Refuse-to-File (RTF) action by the US FDA. Therefore, BLA sponsors prefer to be associated with a substantial Regulatory partner with significant experience in Regulatory consulting for Biologics and Biosimilar products.

Freyr assists sponsors with end-to-end Regulatory support for the BLA submission process, starting from pre-BLA /BPD meetings to post-approval Life Cycle Management (LCM) activities. Additionally, our experienced team members provide Regulatory support for marketing authorizations and relevant LCM for various biological products that are approved in both the Regulatory paths (i.e., 351(a) Innovator Biologics Regulatory pathway and 351(k) Biosimilar Regulatory pathway).

Freyr Expertise

Pre-submission and strategic support in identifying the optimal Regulatory submission pathway for BLA filing.
Regulatory support in scheduling the BLA FDA meetings (Type A, B, C, and BPD meetings for Biosimilars) and various Agency interactions.
Regulatory gap-analysis (review of developmental data/analytical similarity assessment data), preparation of Regulatory mitigation plans, and Regulatory strategy for both 351(a) BLA submission and 351 (k) BLA submission to avoid RTF challenges.
Compilation, technical review, finalization, and submission of BLA package for several types of biological/biosimilars products (vaccines, recombinant therapeutic protein products, monoclonal antibody products, cellular and gene therapy products, etc.)
Regulatory consulting on Biologics drug development programs and request for expedited review program designations (fast track, breakthrough therapy, accelerated review, & priority review).
Request for Regenerative Medicine Advanced Therapy (RMAT) designation for cell therapy, therapeutic tissue engineering product, or human cell and tissue products.
Regulatory strategy for HA queries, Complete Response Letter (CRLs), preparation, and on-time submission of responses to the US FDA queries.
Regulatory support for submission of post-approval LCM submissions (supplements PAS, CBE 30, CBE/BLA annual reports).

What Our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is 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 look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company

Biologics License Application (BLA)

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