Freyr, a leading global Regulatory solutions and services provider, announced that the organization has recently obtained the US Food and Drug Administration (US FDA) 510(k) clearance and the Health Canada (HC) Medical Device License (MDL) clearance for Cocoon Medical – a Spain-based leading manufacturer of energy-based aesthetic medical devices. The project was completed within a quick turnaround time, i.e. in less than 4 months.
Cocoon Medical approached Freyr for comprehensive Regulatory support to register their laser-based hair removal devices, Primelase and Elysion, with the US FDA and the Health Canada respectively. As the Spain-based device manufacturer was new to the U.S. market, Freyr not only took upon the challenge of decoding and communicating regional Regulatory scenario to Cocoon Medical, but also made them align with requirements on time. Further, the leading Regulatory service provider also assisted Cocoon Medical to comply with the Health Canada’s new requirement of MDSAP that is effective from January 1, 2019. Freyr initiated series of interactions with the Health Canada to lay a clear pathway for the smooth transition.
Freyr assisted Cocoon Medical by taking up necessary measures like thorough review and gap analysis of technical files, compilation of e-Submission package, and responding to the Agency queries right on time.
“This is yet another milestone for Freyr. We feel accomplished not only in receiving the MDL and 510(k) notification clearance from the Health Canada and the US FDA in quick turnaround time, but also to ensure the clients’ quick market-entry and improved business prospects,” said Suren Dheenadayalan, CEO, Freyr. “This success will definitely be a gateway to obtain many such crucial global approvals in future, and we bank only on clients’ unparallel trust on Freyr to see that come into light,” 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, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Austria, Sri Lanka and has Global Delivery Center in Hyderabad, India.
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