Regional Expertise

 

Regional Expertise - Overview

Freyr is a leading Regulatory affairs services organization and has been a pioneer in offering strategic, multidisciplinary Regulatory affairs consulting services worldwide. Freyr provides comprehensive Regulatory affairs services throughout the spectrum of global product development, registration, and commercialization. To assist organizations to maximize their product’s commercial capability and market success, Freyr partners with the specific organization's in-house teams to deliver informed advice and Regulatory affairs consulting offerings and solutions for brand new product and marketplace authorizations, Health Authority submissions, submission approvals, CMC, and lifecycle management.

Freyr’s worldwide Regulatory affairs offerings enable Life Sciences, Consumer Pharma, and Bio-Med companies to understand and successfully manage the demanding complexity of various Regulatory requirements to correctly launch their products in new markets and maximize their market value.

Regional Expertise - Expertise

Europe, Australia, NZ
  • Regulatory strategy and submission roadmaps
  • Support in identifying the submission procedures
  • Meetings with EMA/other HAs
  • Content for pre-submission meetings
  • CMC writing of IMPD/MAA/Hybrid Applications/ASMF/CEP
  • Pre-GMP clearance application for TGA
  • Product roll-out
  • Post-approval submissions (i.e., variations)
  • Lifecycle management i.e., renewals filings
  • Response to queries
  • Legacy dossiers gap-analysis and remediation
  • End-to-end Regulatory consultation
  • Change control evaluation and compliance support
  • Site transfers
Regional Expertise
North America
  • Regulatory strategy and submission roadmaps
  • Packages for pre-submission meetings for INDs/NDAs/ANDAs
  • CMC writing of IND/NDA (505(b)1/2)/ANDA/ANDS/DMF
  • Updating paper INDs into eCTD format
  • Response to queries
  • Change control evaluation and compliance support
  • Lifecycle management (i.e., annual reports, amendments, and supplements)
  • Gap-analysis and remediation
  • End-to-end Regulatory consultation
  • Updating USA DMF in-line with the current GDUFA requirements
  • Updating paper DMFs into electronic DMFs
Africa, CIS, SSA
  • Regulatory strategy and submission roadmaps
  • CMC writing of MAA/DMF
  • Renewals
  • Update of DMFs in CTD/eCTD format
  • Product roll-out
  • Response to queries
  • Post-approval changes
  • Gap-analysis and remediation
  • End-to-end Regulatory consultation
  • Site transfers
Asia Pac, Middle East
  • Regulatory strategy and submission roadmaps
  • CMC writing of dossiers/DMFs
  • Gap-analysis and remediation
  • End-to-end Regulatory consultation
  • Site transfers
Latin America
  • Regulatory strategy and submission roadmaps
  • CMC writing of dossiers/DMFs
  • Gap-analysis and remediation
  • End-to-end Regulatory consultation

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​