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!

Freyr transformed the Regulatory Intelligence Ecosystem in a Global Bio-Pharmaceutical Company by building a World-class, Custom Regulatory Intelligence product
GRI

Freyr transformed the Regulatory Intelligence Ecosystem in a Global Bio-Pharmaceutical Company by building a World-class, Custom Regulatory Intelligence product

Join us on a remarkable journey as Freyr transforms the Regulatory Intelligence ecosystem for a top 5 global bio-pharmaceutical giant. Faced with fragmented Regulatory and decision-making processes, our custom solution integrated advanced technologies to centralize their records and streamline global compliance tracking, truly transforming their Regulatory intelligence processes.

Freyr enabled a South Korean AI Software manufacturer to expand their SaMD market with cutting-edge solutions via tailored Regulatory Lifecycle Management services
Medical Devices

Freyr enabled a South Korean AI Software manufacturer to expand their SaMD market with cutting-edge solutions via tailored Regulatory Lifecycle Management services

The customer’s portfolio comprised of 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. Freyr played a pivotal role, providing tailored Regulatory strategies and market entry solutions to accelerate their global expansion across multiple countries spanning ASEAN, MENA, and LATAM regions.

Freyr leads the establishment of a new Regulatory Intelligence function within a Large Size Innovator Pharmaceutical Entity through Bespoke Staffing solution and Consultancy services
GRI

Freyr leads the establishment of a new Regulatory Intelligence function within a Large Size Innovator Pharmaceutical Entity through Bespoke Staffing solution and Consultancy services

Uncover the story of a prominent EU pharmaceutical innovator grappling with Regulatory intelligence hurdles. Drowning in data from multiple tools, they struggled with inefficient processes and reactive decision-making. Freyr's tailored 360-degree consulting approach came in as a complete game-changer, significantly boosting efficiency and reducing operational costs.

Freyr Managed 15+ New and Approved Products (ANDAs/NDAs) for a Leading US Pharmaceutical Company with Comprehensive Regulatory Operations Support
Medicinal Products, Regulatory Affairs

Freyr Managed 15+ New and Approved Products (ANDAs/NDAs) for a Leading US Pharmaceutical Company with Comprehensive Regulatory Operations Support

A leading US pharmaceutical company had faced significant challenges in managing over 15 new and approved products (ANDAs/NDAs) due to a lack of in-house Regulatory expertise and limited FDA knowledge. Seeking comprehensive Regulatory support, they had turned to Freyr. Freyr's expert team provided strategic guidance, submission support, and ongoing Regulatory operations management, offering end-to-end Regulatory solutions that ensured seamless submission processes and continuous Regulatory compliance. As a result of Freyr's support, the pharmaceutical company achieved zero rejections and maintained Regulatory excellence.

Freyr supported a German-based Pharma and Medical Device leader with technical writing services throughout the Device Lifecycle of their SaMD radiology solution
Medical Devices

Freyr supported a German-based Pharma and Medical Device leader with technical writing services throughout the Device Lifecycle of their SaMD radiology solution

The customer required Freyr to migrate content from the legacy application (FrameMaker) to Vasont Inspire Component Content Management System (CCMS). Freyr tailored Technical Writing solutions enabled the customer to achieve their goal with a 40% quicker turn-around-time.

Freyr Facilitated Seamless Management of Over 70 ANDAs/NDAs for a US-based Pharmaceutical Company Through Comprehensive End-to-End Regulatory Support
Medicinal Products, Regulatory Affairs

Freyr Facilitated Seamless Management of Over 70 ANDAs/NDAs for a US-based Pharmaceutical Company Through Comprehensive End-to-End Regulatory Support

A US-based pharmaceutical company had faced high attrition rates and limited in-house expertise, struggling with the Regulatory operations of 70+ ANDAs/NDAs. They had turned to Freyr for comprehensive Regulatory services. Freyr had provided strategic guidance and submission management, transforming the company's Regulatory operations. This support ensured seamless operations, timely approvals, and enhanced compliance.

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.

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    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.

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    Regulatory Software

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

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    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.

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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, and authenticated Regulatory information at your fingertips.

 

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.

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.

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