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