New Jersey – July 01, 2019: Freyr, a leading global Regulatory solutions and services provider, announced that the organization has obtained Health Canada (HC) Medical Device License (MDL) clearance for a hair removal device from the product lines of a Spain-based medical device manufacturer.
The clearance is all rooted to the client’s product registration requirements in Canada. This includes interacting with Health Authority to address the queries about client’s previously registered device and taking up necessary measures for new device registration in terms of guiding the client with thorough review and gap analysis of technical files, HC’s MDSAP transition, and compilation of e-Submission package.
“This is yet another milestone for Freyr. Apart from receiving MDL clearance from the Health Canada, obtaining it with no queries and in quick 4 months’ time is very satisfactory. As a Regulatory services provider we feel accomplished, especially to see the clients’ quick market-entry and improved business prospects,” said Suren Dheenadayalan, CEO, Freyr. “We would also like to take this opportunity to thank our clients for putting their faith in us. This will definitely be a gateway to many such crucial approvals with global Health Authorities for many more 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, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Austria, Sri Lanka and has Global Delivery Center in Hyderabad, India.
- 300+ global clients and growing
- 600+ 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