Regulatory Strategy Consulting Services

Freyr, a trusted Regulatory Affairs consulting partner, addresses complex challenges in pharmaceutical development and commercialization by offering expert guidance on regulatory strategies, compliance, and global market navigation.

Regulatory Strategy Consulting Services - Overview

The most common challenges faced by the pharmaceutical industry are the optimal investment of time and money and effective Regulatory strategy consulting services to safeguard compliance to fulfill business goals. Expert Regulatory strategy consulting support and well-defined Regulatory affairs consulting services are essential in dealing with challenges in product commercialization and the drug development process. Some of the key challenges faced include the following:

  • Regulatory strategy to resolve drug developmental issues (impurities, analytical, stability, container closure-related issues, etc.).
  • Regulatory strategy and planning of huge work volumes triggered due to acquisitions/business integrations.
  • Strategic planning for a global clinical trial during drug development.
  • Strategic planning of Regulatory submissions with minimum available data at the time of the submission or with anticipated Regulatory risks.
  • Reference Medicinal Product (RMP)-related challenges when dealing with more than one (01) market.
  • A well-defined Regulatory strategy consulting service supports Complete Response Letter (CRL) submission to Health Authorities (HAs) or response to HA queries.
  • Strategic planning to take the products approved in one region to other regulated markets (for example, from the USA to Europe, or vice versa).

Therefore, the right Regulatory Affairs consulting services partner is key to the successful commercialization of medicinal products. With a proven track record of keeping abreast of global market conditions and navigating customers through their unique Regulatory requirements, Freyr acts as a preferred Regulatory Affairs consulting services provider and strategic partner for global pharmaceutical and biotechnology companies.

Regulatory Strategy Consulting Services

  • Submission planning for various Regulatory applications in the global market.
  • Regulatory compliance consulting to address agency queries and CRLs.
  • Preparation and submission of Biological License Applications (BLAs)/Marketing Authorization Applications (MAAs) for recombinant therapeutic proteins, vaccines, and other biological advanced therapy products such as stem cells and tissue-based products.
  • CMC consulting support in the preparation and submission of Regulatory dossiers like INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMF, ASMF, IMPD, etc.
  • Regulatory submission strategy for drug expansion in another market.
  • Regulatory compliance consulting for the implementation of post-approval changes.
  • Regulatory consulting for pre-submission interactions with HAs.
  • Competitors’ landscape evaluation and preparation of the right Regulatory strategies/mitigation plans that suit product registrations ahead of using expedited program requests.
  • Regulatory Affairs consulting for Orphan Drug Designation (ODD) applications and also other expedited programs.
  • CMC consulting for Quality by Design (QbD) protocols and reports.
  • CMC consulting for the development of biosimilars/biological products.
  • Pharmaceutical Regulatory consulting services for entering new markets.
  • Regulatory consulting in dealing with developmental issues of a combination of products (Device + Drug/Biologic).
  • CMC consulting for evaluation of pharmaceutical excipients against the IIG database.
  • Regulatory compliance consulting in defining the tests/risk assessments for genotoxic impurities, elemental impurities, etc.
  • CMC consulting and stability study requirements considering bracketing and matrix concepts.
  • Regulatory strategy and identification of RMPs for the global market.
  • Identifying the submission process in Europe.
  • Regulatory affairs consulting in the selection of Reference Member State (RMS).
  • Regulatory compliance consulting in responding to HA queries.
  • Consulting support for change in formulation/route of administration of drugs and the registration of dossier to HAs (for example, 505b (2), hybrid applications, etc.).
  • Regulatory consultants who are up to date with the Regulatory changes.
  • Compliance with the Regulatory requirements of global HAs.
  • Experienced team of pharma Regulatory consultants.
  • Designing the ideal Regulatory affairs strategy.

Avail expert regulatory strategy consulting

Partnering with Leading Organizations

 

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

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

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​