New Jersey, May 29th , 2018 - Freyr, a leading global Regulatory solutions and services provider, has successfully assisted a major medical device manufacturer in attaining the US Health Authority approval for their advanced wound care products. Incidentally, the client has become the first Indian wound care product manufacturer to attain 510(k) clearance from the United States Food and Drug Administration (USFDA).
Freyr has meticulously strategized and compiled a 510(k) submission for the client, eventually procuring 510(k) clearances with the US FDA in expected timelines efficiently. Based on USFDA’s approval, the wound care product can now be marketed as Over the Counter (OTC) product in US.
“This is a significant milestone in Freyr’s growth journey as a specialized regulatory partner and the achievement has got our spirits further up to continue to ensure success for our global clientele. Our best regards for the client who have had their utmost trust in our capabilities,” said Suren Dheenadayalan, CEO at Freyr. “Freyr recently achieved another milestone of working with over 225 clients and this USFDA 510(k) clearance came just in time strengthening Freyr’s position as a preferred global regulatory partner. In line with our vision for future, we will continue to deliver such critical approvals from Health Authorities worldwide that has high business impact for our clients,” added Suren.
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small Size Global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, 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 UK, Germany, UAE, Mexico, Singapore, Malaysia, South Africa and has Global Delivery Center in Hyderabad, India
- 225+ global clients and growing
- 550+ global Regulatory experts
- 700+ regional Regulatory affiliates across 120+ countries
- ISO 9001 Certified for strong process and quality management
- ISO 27001 Certified for information security management, state-of-the-art infrastructure