## [Home Page](/home) ## 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. 120 \+ Countries 2100 \+ Global Customers 2500 \+ In-house Regulatory Experts 850 \+ In-country Regulatory Affiliates 10 Global Delivery Hubs ## Success Stories Powering Progress: Real Regulatory Wins, Transforming Compliance into Success! ![ISO 13485 & MDSAP preparations for SaMD manufacturer](/sites/default/files/styles/large/public/success-stories-thumbnails/so-13485-and-mdsap-preparations-for-samd-manufacturer%20%281%29.png?itok=pD5sLft9) Medical Devices, Digital Health #### ISO 13485 & MDSAP preparations for SaMD manufacturer Strengthening QMS maturity and certification readiness through strategic gap assessment, remediation, and implementation support. [Know More](https://preprod.freyrsolutions.com/success-stories/iso-13485-mdsap-preparations-for-samd-manufacturer) ![Comprehensive Regulatory Operations for 70+ ANDAs/NDAs Enabled Business Continuity for a US based Pharma Company](/sites/default/files/styles/large/public/success-stories-thumbnails/Comprehensive-Regulatory-Operations-Thumbnail.webp?itok=YnKRHIMp) Medicinal Products, Regulatory Affairs #### Comprehensive Regulatory Operations for 70+ ANDAs/NDAs Enabled Business Continuity for a US based Pharma Company A US pharmaceutical company, with a lean Regulatory CMC team and high attrition, struggled to manage over 70 ANDAs/NDAs. Freyr became an end-to-end Regulatory partner, stabilizing operations, filling critical roles, and maintaining compliance. [Know More](https://preprod.freyrsolutions.com/success-stories/comprehensive-regulatory-operations-for-70-andasndas-enabled-business-continuity-for-a-us-based-pharma-company) ![End to End Regulatory Operations for 15 ANDAs/NDAs Enabled Zero Rejections for a US Pharma Company.](/sites/default/files/styles/large/public/success-stories-thumbnails/End%E2%80%91to%E2%80%91End-Regulatory-Operations-Impact-Thumbnail.webp?itok=kUSaatF9) Medicinal Products, Regulatory Affairs #### End to End Regulatory Operations for 15 ANDAs/NDAs Enabled Zero Rejections for a US Pharma Company A complete Regulatory operations ownership right from strategy to timely filings translated into zero rejections for 15 ANDA/ NDAs for our customer. [Know More](https://preprod.freyrsolutions.com/success-stories/end-to-end-regulatory-operations-for-15-andasndas-enabled-zero-rejections-for-a-us-pharma-company) ![Global Lifecycle Management Support Strengthened Portfolio Control for a Biopharma Company](/sites/default/files/styles/large/public/success-stories-thumbnails/global-lifecycle-management-support-Thumbnail.webp?itok=WgYGxC_e) Medicinal Products, Regulatory Affairs #### Global Lifecycle Management Support Strengthened Portfolio Control for a Biopharma Company A biopharma company needed structured lifecycle management support for its pharmaceutical portfolio across various global markets. Freyr delivered comprehensive LCM support aimed at streamlining post-approval processes, ensuring submission continuity, and enhancing regulatory oversight across the entire portfolio. [Know More](https://preprod.freyrsolutions.com/success-stories/global-lifecycle-management-support-strengthened-portfolio-control-for-a-biopharma-company) ![Transforming EU MDR Complaint Handling into an Audit-Ready Post-Market Framework](/sites/default/files/styles/large/public/success-stories-thumbnails/Transforming%20EU%20MDR%20Complaint%20Handling%20into%20an%20Audit-Ready%20Post-Market%20Framework%20-.png?itok=xeUweFKL) Medical Devices, EU Compliance #### Transforming EU MDR Complaint Handling into an Audit-Ready Post-Market Framework Enabling faster reportability decisions, timely MDR submissions, and inspection-ready complaint handling for high-volume medical device portfolios [Know More](https://preprod.freyrsolutions.com/success-stories/transforming-eu-mdr-complaint-handling-into-an-audit-ready-post-market-framework) PreviousNext ## 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. - [1](/global-regulatory-services) ##### 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](/global-regulatory-services) - [1](https://www.freyafusion.com/) ##### Your AI-First Regulatory Cloud by Freyr Transform Your Regulatory Operations with freya fusion – an AI-first, unified regulatory platform designed to manage your entire regulatory lifecycle and be the single source of truth for your data. Streamline processes, ensure compliance, and accelerate time-to-market with intelligent automation and connected workflows. [Know More](https://www.freyafusion.com/) - [1](https://www.freyrregintel.com/) ##### Global Regulatory Intelligence Stay ahead of the ever-evolving regulatory landscape with Freyr GRI. Powered by AI, NLP and ML technologies, our tailored and data-driven insights empower you to make informed strategic decisions with confidence and ease. [Know More](https://www.freyrregintel.com/) [1](https://www.freyrregintel.com/freya-intelligence/) ##### Your AI-Enabled Regulatory Wiz by Freyr 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, and authenticated Regulatory information at your fingertips. [ ](https://www.freyrregintel.com/freya-intelligence/) ## Celebrating Customers Success 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. Medical Devices Registration and LR Services Global While competitive pricing initially drew us to Freyr, it’s their outstanding service and professionalism that have secured our ongoing partnership. Their ability to deliver quick turnarounds, respond promptly, and expertly manage our projects continues to impress. Freyr’s strong market expertise and deep understanding of our devices make communication seamless and efficient. Having a single point of contact for our global registrations has been a game-changer, simplifying processes and ensuring consistency across markets. Freyr’s knowledge of our products and Regulatory needs in different countries saves us significant time and effort. Freyr’s proactive support, even flagging potential issues before they arise, demonstrates their dedication to our success. I wholeheartedly recommend Freyr to anyone seeking dependable, high-quality Regulatory services. ##### Anastasya Melnikov RAQA Manager Medical Devices Registration and LR Services Global As an AI-driven medical device company, we faced complex global Regulatory challenges, especially around SaaS and digital health solutions. Freyr’s deep expertise in medical device regulations, particularly for AI technologies, and Freyr’s global reach across EU and US markets made them the ideal partner. Their team brought clarity, structure, and a proactive approach, seamlessly integrating with ours as a true extension of our Regulatory function. Thanks to Freyr, we reached critical Regulatory milestones more efficiently, with successful submissions and timely approvals that reduced our compliance risks and accelerated market entry. Freyr’s professionalism, knowledge, and commitment to quality make them a trusted partner for any company seeking Regulatory excellence in the evolving medical device landscape. ##### Head of Regulatory and Risk A Leading AI SaMD Manufacturer Medical Devices Registration and LR Services Global Many, many thanks to the amazing team at Freyr Solutions for all your efforts and tireless support, making us the world leader in AI-driven dental solutions. We are grateful for all you have done and continue to do ##### Bill Birdsall Chief Compliance Officer Food Supplements Freyr exceeded our expectations by delivering a hassle-free and smooth product registration experience in the EU. Their team was professional, responsive, and always ready to provide clarity when needed. As a result, we are now confidently operating in five EU countries with our dietary supplements, thanks to their expert guidance and flawless execution. We highly recommend Freyr for regulatory support. ![QC & Regulatory Manager]() ##### Bien Almonte QC & Regulatory Manager Cosmetics End-to-end regulatory services Global It has been a pleasure working with Freyr, thanks to the seamless project delivery and the value your team consistently brought to the table. The expertise and professionalism demonstrated have exceeded expectations. I look forward to future opportunities to collaborate. ![Hairburst]() ##### KASIA FRANKOWSKA Head of Regulatory Affairs 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. ![Regulatory Affairs]() ##### Arie Henkin VP - Quality and Regulatory, Australia -based, Leading SaMD 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 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. ![Regulatory Affairs]() ##### Darren Mansell Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing 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 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. ![Regulatory Affairs]() ##### Robert Menadue Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company 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 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. ![Regulatory Affairs]() ##### Sergey Burlov Quality Manager, Russia-based, Innovative SaMD Company Cosmetics  End-to-End Notification Services Indonesia, Philippines, Thailand We love working with you and have been very impressed with your team, so we plan on introducing our own branded products (or other white-label products) in Indonesia with you in the future. ##### Partner US-based, Leading Cosmetics Manufacturing Company 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. ![Regulatory Affairs]() ##### Pascale LE BAUD Regulatory Affairs Associate - RA Department, France-based, Leading Synthetic Implants Manufacturing Company Food Supplements Product Compliance India It has been a pleasure to work with Freyr. The team played a big part in launching out product in India. I thank everyone on the team. ##### Director US-based, Leading Nutritional and Herbal Supplements Manufacturing Company Food Supplements FSSAI Registration India Thank you Freyr! Your SME was a star during this whole process. What you did for us is hugely appreciated. I am looking forward to continuing to work with Freyr. So, thanks you everyone on the team at Freyr. ##### Director US-based, Leading Nutritional and Herbal Supplements Manufacturing Company Cosmetics Regulatory Competitive Intelligence UK Thank you for reaching out and letting me express the awesome work that Freyr provided for both projects that met the cost and project deliverables. Outstanding Freyr Team! You guys rocked! We are delighted with the outcome of these, and we are in the process of sharing them with our management and our department. I want to especially give a shout-out to Freyr's resource, as she provided outstanding technical leadership and output that met our expectations. With that said, we are looking forward to partnering with you for future projects. ##### Global Regulatory Affairs, Discovery US-based, Leading Consumer Health Care MLM Company Chemicals Training Manuals Project Update Global Congratulation to the entire Freyr Solution team!!!! It has been a complex exercise for both parties, and I am so glad we got to a successful end. As you can imagine, we are facing a new situation due to COVID-19. We are focused on delivering business targets and to establish new necessary ways of working. ##### Group Leader US-based, Multinational Food and Beverage Company Food Supplements Immunity Boosting Supplement USA It was indeed a pleasure having availed your service and we are happy that you could guide us through and complete the label design of our product. We are thankful to you! ##### General Manager India-based, Global Dietary Supplements Company Cosmetics End-to-End Product Registration India Thank you so much for sharing good news and registration certificates. With your prompt follow-up and support, we received registration certificates so much earlier than we initially expected! We appreciate your services and professionalism. And I hope we will work on new projects with you very soon. ##### Manager International Business South Korea-based, Leading Export & Import Services Company PreviousNext ## Functional Delivery Models Shaping the future of Regulatory excellence! - [  The FSP Model](/functional-delivery-models) - [  The RAaaS Model](/functional-delivery-models#raaas-model) - [  Comprehensive Outsourcing/ Full-service Model](/functional-delivery-models#full-service-model) - [  Hybrid Model](/functional-delivery-models#hybrid-model) - [  Project-based Outsourcing](/functional-delivery-models#project-based-outsourcing) - [  Offshore/ Nearshore Outsourcing](/functional-delivery-models#offshore) - [  Co-sourcing](/functional-delivery-models#co-sourcing) - [  Regulatory Intelligence and Strategy Services](/functional-delivery-models#regulatory-intelligence) - [  Staff Augmentation](/functional-delivery-models#staff-augmentation) - [  Regional/ Localized Delivery through Affiliate Network](/functional-delivery-models#regional-localized) ## 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](javascript:void(0)) ![Connect with Freyr]()