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Follow on Google News | Freyr's 510 (k) Compilation Receives the USFDA Approval For an Indian Wound Care CompanyNew Jersey, 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.
By: Freyr Solutions 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," About Freyr 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; • 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- End
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