Regional Regulatory Affairs, Regulatory Strategy, RA consulting

Global Regulatory Affairs Experience

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.

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

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

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

Global Regulatory Affairs Experience

EUROPE, AUSTRALIA, NZ

NORTH AMERICA

AFRICA, CIS, SSA

ASIA PAC, MIDDLE EAST

LATIN AMERICA

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