New Jersey, January 06, 2020: Freyr, a leading global Regulatory solutions and services provider, announced that the organization has successfully obtained approvals for 100+ Medical Devices and IVDs within a span of two years. These medical devices range from low-risk to high-risk categories and have been approved by all the major health authorities (HA) across the globe.
Freyr partnered with various large to mid-sized Medical devices companies to classify and register their products across the regions irrespective of their class ranging from Blood collection tubes, IVDs, Laser hair removal, Cardiovascular, Wound Dressing, Dermal Fillers, Lancets, Catheters, Digital devices, Borderline products etc.
In addition, Freyr has been successful in interacting and conducting pre-submission meetings with major Health Authorities like USFDA (USA), Health Canada (Canada), Thai FDA (Thailand), FDA (Philippines), CDSCO (India), CE (Europe), COFEPRIS (Mexico), CAPA (Kenya), NDA (Uganda), ANMAT (Argentina), MHRA (UK), NPRA (Malaysia), ANVISA (Brazil), NAFDAC (Nigeria), DRAP (Pakistan) etc.
“As a leading Regulatory service provider, Freyr has already proven its mettle in all the life sciences verticals. With this achievement of 100+ medical device approvals, in a span of just two years, Freyr has reestablished itself as a niche service provider with an impressive track record in the medical devices and IVD Space,” said Suren Dheenadayalan, CEO, Freyr. “It is not just the outcome of our comprehensive understanding of medical devices and global Regulatory standards alone. It is the free hand clients have given to us to ensure their successful and compliant product launch,” 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.
- 450+ global clients and growing
- 650+ 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