New Jersey – November 11, 2020: Freyr, a leading global Regulatory solutions and services provider, announced successful submission and approval of a New Dietary Ingredient Notification (NDIN) to the United States Food and Drug Administration (US FDA) for a South Korea based leading organization in food industry.
Considering the business requirements of the client, Freyr completed the entire application within just few months in line with clients’ business requirements and submitted the application in the month of July 2020 to the US FDA. Against the usual timeline for NDIN approval, i.e. ninety (90) days, US FDA has approved client’s NDIN within Fifty (50) days, with no substantiate amendment in the dossier submitted.
The NDIN was the client’s first formulation submission to the USFDA in food industry and the client wanted no stone to be left unturned to make it successful. In addition to performing required gap analysis for clients’ new dietary supplement, a challenging aspect Freyr had to encounter was the compilation of the entire dossier in a short span and to prove the appropriate amount of dosage of the food ingredient using the available data. Freyr, with a strategic and systematic approach, deployed a large number of regulatory experts to complete the NDIN submission within the stipulated timeline, and in-turn, received the approval from the US FDA in a much lesser expected time.
“Obtaining the US FDA’s approval for the NDIN in such a short timeline was not only a great breakthrough for client’s first ever formulation submission, but also for Freyr to ensure clients’ business continuity with a strategic Regulatory approach,” said Suren Dheenadayalan, CEO, Freyr. “This project stand as a true testimony to Freyr’s quick turnaround time for critical submissions,” 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, (Consumer Healthcare | Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Cosmetics | Chemicals) 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.
- 600+ global clients and growing
- 800+ global Regulatory experts
- 800+ 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