about-us

About us

Freyr is the largest global Regulatory solutions and services provider, offering end-to-end solutions to the Pharmaceutical, Medical Devices, and Consumer sectors. At Freyr, we specialize in Regulatory Affairs, Pharmacovigilance, Quality Management, and Technology Solutions for Submissions Management, Labeling Management, Regulatory Information Management, and Regulatory Intelligence.

With our deep industry expertise, global presence, and commitment to innovation, we empower clients to navigate complex Regulatory landscapes efficiently and effectively. From Regulatory strategy to submissions and compliance, we are your trusted partner in ensuring product success and patient safety.

20

+

Strategic Global Locations
1500

+

Global Customers
2100

+

In-house Regulatory Experts
850

+

In-country Regulatory Affiliates
8
Global Delivery Hubs

Success Stories

Powering Progress: Real Regulatory Wins, Transforming Compliance into Success!

fr-success9
Medicinal Products

Freyr’s Seamless Management of End-to-End Regulatory Operations for 70+ Products for a US-Based Pharmaceutical Company

Embark on a journey of Regulatory triumph as Freyr takes the lead in managing end-to-end Regulatory operations for a distinguished US-based pharmaceutical company.

fr-success8
Medicinal Products

Freyr’s Cutting-edge Role in Assisting an Italian Multinational Pharma Company Enter the EU and US Markets

Embark on a journey of Regulatory success with Freyr as we unveil the pivotal role we played in assisting a prominent Italian multinational pharma company’s expansion into the competitive markets of the EU and the US.

fr-success7
Medicinal Products

Crafting Success: Freyr’s Strategic Approach and Regulatory Support for a Complex Generic Product Development Meeting (PDM) with the US FDA

Amidst Regulatory complexities surrounding an injectable drug product, an Italian pharmaceutical company sought Freyr’s expert guidance. Their mission? Navigating the intricacies of engaging with the US FDA and securing vital clarifications from HAs.

fr-success6
Medicinal Products

Empowering Innovation with Freyr’s Outstanding Regulatory Assistance for an Italian Pharma’s Enzyme Replacement Therapy’s BLA Preparation

Embark on an exhilarating Regulatory journey with us as we unveil a tale of triumph! Witness how Freyr, with unmatched expertise, guides an Italian pharma and biologics company through the intricate challenges set forth by the US FDA for their enzyme replacement therapy’s BLA preparation.

fr-success5
Medicinal Products

Freyr’s Excellence in Orchestrating End-to-End Regulatory Operations for a Leading US Pharmaceutical Company with Over 15 Products

In the complex, dynamic landscape of the pharmaceutical industry, a mid-sized US-based biopharmaceutical company, specializing in innovative therapies, faced a pivotal challenge. With a portfolio boasting over 15 groundbreaking ANDAs/NDAs and several products in development, the absence of an in-house Regulatory team threatened to stifle their progress.

fr-success4
Medical Devices

Freyr’s Dynamic Staff Augmentation Model for One of the World’s Largest Medical Device OEM Manufacturers Equips them to Adapt to Changing Business Needs while Accessing Specialized Skills and Expertise

The customer, a powerhouse in the global medical device industry, commands a vast presence across 150+ countries and boasts expertise in over 16 therapeutic areas. Recognizing the need to accelerate their capabilities in pivotal functions like Quality Engineering and Regulatory Affairs, they turned to Freyr.

fr-success3
Medical Devices

Freyr Empowered a South Korean AI Software Manufacturer with Cutting-edge Solutions for Regulatory Intelligence (RI), Device Registration, and Authorized Representative (AR) Services for SaMDs

A South Korean medical AI software company possessed two CAD software solutions designed for evaluating chest radiography and mammography images. These SaMDs, approved by the MFDS, Korea, and CE-marked in compliance with the EU MDD, represented moderate-risk technologies. With ambitious plans for expansion, the customer was poised for aggressive growth.

fr-success2
Medical Devices

Freyr Successfully Delivered 100+ SVRs to a Leading Manufacturer of Diagnostics and Biomedical Testing

The customer based out of France provides a wide range of products and services to support R&D in the Life Sciences and other related fields. The customer is in the process of transitioning from compliance with In Vitro Diagnostic Directive (IVDD 98/79/EC) to In Vitro Diagnostic Regulation (IVDR 2017/746) for their IVD products.

fr-success1
Medical Devices

A Huge Success in Technical Writing! Freyr Helped a German-based Pharma and Medical Device Giant with Technical Writing for SaMDs

The customer is a German multinational pharmaceutical and life sciences company, in addition to being one of the largest pharma companies in the world. They required Freyr to migrate content from the legacy application (FrameMaker) to Vasont Inspire Component Content Management System (CCMS).

Redefining Regulatory Excellence

Take advantage of our integrated suite of services, which range from end-to-end Regulatory consultation, process automation with robust Regulatory software, and harnessing the power of Artificial Intelligence (AI) in Regulatory intelligence, to transforming market entry challenges into growth opportunities.

  • Freyr

    Global Regulatory Services

    Navigate Regulatory complexities effortlessly with our end-to-end global services. From strategy to compliance, we've got you covered globally. Ensure success in every market with Freyr Solutions.

    Know More

  • Freyr Digital

    Regulatory Software

    Elevate your Regulatory efficiency with Freyr Regulatory Software. Streamline processes, ensure compliance, and conquer global markets seamlessly with our advanced Regulatory solutions.

    Know More

  • Freya

    The First AI Regulatory Wiz

    A Regulatory context-trained advisor that allows you to harness the power of Regulatory information with exceptional accuracy and ease. Freya allows you to ask questions and provides verified, referenceable.

    Know More

  • Taevas

    Your partner for Expert Post-Regulatory Solutions

    Specializing in turning market entry challenges into growth opportunities and helping your business thrive in the new markets with strategic market access solutions.

    Know More

Partnering with Leading Organizations

We are proud partners to a diverse range of industry leaders. Our commitment to excellence in Regulatory services has earned us
the trust of esteemed organizations.

 

Medicinal Products

Publishing and Submission

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!

Publishing and Submission
Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medical Devices

Registration and LR Support

Global

Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.

client-speack-logo4
Arie Henkin

VP - Quality and Regulatory, Australia -based, Leading SaMD 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.

Regulatory Affairs
Lynne McGrath

Regulatory Consultant

 

Medical Devices

Swiss Rep Services

Japan and Switzerland

I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.

client-speack-logo3
Darren Mansell

Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Publishing and Submission
Ed Venkat

Global CMC Technical Lead

 

Medical Devices

UKRP Support

UK

FREYR has accompanied us with the registration of several products on the UK market. They have always been quick to reply, attentive to our needs, a great source of Regulatory information and support. The price is reasonable compared with other similar service providers. We particularly appreciate the personalized quarterly and annual status reports that Freyr provides. When we call on FREYR, we know they will do their best to satisfy our needs, and that customer satisfaction is a priority.

client-speack-logo5
Pascale LE BAUD

Regulatory Affairs Associate - RA Department, France-based, Leading Synthetic Implants Manufacturing Company

 

Medical Devices

Registration and AR Services

Malaysia and Indonesia

Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.

client-speack-logo2
Robert Menadue

Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company

 

Medical Devices

Registration and LR Services

Brazil

We are impressed with Freyr’s support in providing us with quick and well-detailed solutions to our queries. Freyr’s constant support to adapt to ever-changing Regulatory conditions while providing support with any additional queries we had in a timely manner has truly impressed us.

client-speack-logo1
Sergey Burlov

Quality Manager, Russia-based, Innovative SaMD Company

Let Us Innovate and Succeed Together

Connect with Freyr, your Gateway to Regulatory Excellence!  

Time is of the essence as we navigate the intricate world of regulations. Take control of your compliance journey today and allow our team of experts to guide you toward success. With our customized solutions, you would always be ahead in the constantly evolving Regulatory landscape, ensuring the growth and sustainability of your business. Let's collaborate and succeed together.

Contact Freyr Now

Connect with Freyr