Freyr Announces Successful Submission of a Complex Application through SUGAM

New Jersey, December 13, 2021 - Freyr Solutions, announces successful submission of a complex Application to the Drugs Controller General of India (DCGI). The submission was made through an online portal – SUGAM – of the CDCSO, and it was for the grant of a Registration Certificate.

In brief, a South Korean life sciences pharmaceutical company approached Freyr to be their local authorized Indian Agent to register their parenteral formulations. Freyr supported the client for Marketing Authorization Transfer (MAT) and appointed Frey as their Local Authorized Indian Agent (MAH) from their existing LR and import registration of their products. Freyr acted as a Local Authorized Indian Agent and RC holder for six (06) Pharmaceutical products.

It is one of the important milestones for Freyr to act as a Local Authorized Indian Agent to hold Registration Certificate, said Suren Dheenadayalan, CEO, Freyr. “It gives us immense pleasure that we have successfully submitted an online application to the DCGI via SUGAM. The entire credit goes to the team’s constant dedication, hard work, and patience throughout the process of performing the GAP analysis, compilation, review, and submission to the DCGI,” added Suren.

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 | 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 the UK, Germany, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Sri Lanka, Australia, Poland, and a Global Delivery Center in Hyderabad, India.

  • 850+ global clients and growing
  • 1100+ global Regulatory experts
  • 850+ 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