New Jersey, Feb 07, 2022 - Freyr, one of the largest, global, Regulatory-focused solutions and services companies for the Life Sciences industry is pleased to announce its association with a fast-growing and innovative South Korean manufacturer of SaMD products. Freyr lead the enterprise to expand globally and market its products in 10 countries; in the past year alone Freyr has supported in 16 successful approvals for 2 devices, globally.
Over the last few years, the amount of software used both in and around medical devices has significantly increased. As this leading edge technology continues to cause a seismic shift in how healthcare is administered and delivered, software has become an increasingly widespread and crucial component of modern medical devices. The medical device industry is very dynamic in nature, and the local regulations are ever-changing. Considering this flux, Freyr has developed cutting-edge Regulatory software to track regulation changes.
Digital Health and Artificial Intelligence seem to be the future of technology and healthcare, Health Agencies are strengthening their respective regulations to ensure safe and effective devices from these upcoming technologies are made available in the market. Considering all these, obtaining approval for AI-based products in various countries adds to Freyr’s achievements.
After evaluating Freyr’s capabilities, this South Korean company initially approached Freyr for its Regulatory Intelligence (RI) reports. Freyr Subject Matter Experts (SME) team provided the quality reports, which was a deciding point for the company to choose Freyr over the other Regulatory service providers. In their global market expansion strategy, the company was aiming to launch their products in 10 countries which included regulated and semi-regulated markets. To get ahead with approvals in multiple countries, the Freyr team consolidated required documentation for each country, collected them from the company and prepared a package for each country’s Regulatory authority. Freyr successfully obtained 16 approvals. Some of these approvals were obtained in the record time of 15 days, due to the highest quality of documentation executed by the team. The approvals in a very short span of time highlights Freyr’s commitment for companies to launch their products faster. Freyr has well established PMO and processes to coordinate between teams located in multiple countries. As the company appointed Freyr as their Local Representative in all these countries, they were able to achieve significant ROI.
“Freyr has always been a trusted partner for all its clients, and this medical AI software company is one such example. Obtaining approval in 10 countries within the stipulated timeframe was the result of smooth communication among all stakeholders of the project. As AI-based products have multifaceted Regulatory requirements, this project stands as a true testimony of Freyr’s clear understanding of SaMD products’ Regulatory landscape worldwide”, said Vasu Ranabothu, Regional Head, Freyr.
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium, and Small Size Global Life sciences companies which are including innovative and generic pharmaceutical products, as well as medical device, biotechnology, biosimilar, consumer healthcare, cosmetics and food supplements products. Freyr provides end-to-end services in their entire Regulatory value-chain, ranging from Regulatory strategy, intelligence, dossier preparation, submissions, etc. to post-approval / legacy product maintenance, labeling, artwork change management, and other related functions.
Headquartered in New Jersey, USA, Freyr has regional offices across the UK, Germany, UAE, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Poland, Australia, Sri Lanka, France, Switzerland, China and India.
- 950+ global clients and growing
- 1200+ in-house Regulatory experts
- 900+ in-country Regulatory affiliates
- ISO 9001 Certified for strong process and quality management
- ISO 27001 Certified for information security management, state-of-the-art infrastructure