Regulatory Submission Roadmaps/Regulatory Intelligence Services

We offer tailored Regulatory Intelligence support to decipher updated Regulatory requirements, devise optimal submission strategies, and facilitate seamless product commercialization across global markets.

Regulatory Submission Roadmaps/Regulatory Intelligence Services - Overview

Regulatory requirements are dynamic and stringent in the development, manufacturing, and distribution of biopharmaceutical products. Given the nature of global regulations, medicinal products manufacturers face challenges in understanding the updated Regulatory compliance requirements, choosing the right Regulatory submission roadmap, and developing an appropriate Regulatory strategy to enter the global markets.

The ideal way to overcome such Regulatory challenges is comprehensive Regulatory intelligence (RI) support to define appropriate Regulatory strategy. Regulatory Intelligence is evaluating the Regulatory framework for targeted country/countries, identifying the regulations and Health Authority (HA) guidance for the medicinal product approval process, registration-dossier submission requirements, import licensing, and collating insights on practical challenges with the HAs during the application review and approval processes.

With an overview of the targeted country, product classification, and registration requirements, including the specific requirements for CMC, nonclinical, clinical, labeling, GMP requirements, and import regulations, a detailed Regulatory Intelligence report with a submission roadmap will help manufacturers arrive at a Regulatory strategy to commercialize the product in the country. 

Freyr has a proven track record in supporting medicinal products manufacturers with the best Regulatory Intelligence and Regulatory submission strategies to commercialize medicinal products, globally.

Regulatory Submission Roadmaps/Regulatory Intelligence Services - Expertise

  • Strategic support in identifying the optimal pathway for different applications in the global market (US, EU, Japan, Canada, Australia, and RoW).
  • Innovative Licensing and Access Pathway (ILAP) consulting for the UK.
  • Identification of Regulatory requirements and mitigation plans for the targeted countries.
  • Intelligence on medicinal product’s market entry.
  • Intelligence on global clinical trial programs and large-scale product registration activities.
  • Competitors’ landscape evaluation to prepare the right Regulatory strategy for product registrations.
  • Product evaluation for suitability under expedited programs and Regulatory support for submitting expedited program requests (Fast Track designations, Breakthrough Therapy designations, Accelerated Approval process, and Priority Review designations).
  • Expertise in developmental issues with various medicinal products (biologics, small molecules, medical devices, combination products, etc.).
  • Developmental approach and Regulatory submission requirements for complex products.
  • Identification of Reference Medicinal Products (RMPs) per the global commercialization plan and defining the right developmental approach and Regulatory submission roadmap.

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​