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Regulatory Services in India, CDSCO, Regulatory Affairs Consultants in India

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Freyr India
Regulatory Services in India, CDSCO, Regulatory Affairs Consultants in India


Greetings from Freyr India

Freyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. With our presence in 120+ countries, we help Life Sciences companies in their “local to global” journey. At Freyr India, we support companies to register their products with the CDSCO, Regulatory strategy, market intelligence, in-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions covering the complete CDSCO registration life cycle.

Freyr Expertise

  • End-to-end Registration Support
  • Authorized Local Agent Support
  • Manufacturing Site Approval Support
  • Import Registration and Sample Import License Support
  • Regulatory Affairs Consulting
  • Gap Analysis of the Dossier as per the CDSCO Regulatory Requirements
  • Preparation of Gap Analysis Report and Remediation Plan
  • Pharmaceutical Dossier Preparation and Submission to the CDSCO
  • Pharmaceutical Lifecycle Management Support

Know More

Industries We Serve

Central Drugs Standard Control Organization (CDSCO) is an Indian Health Authority under the Drugs and Cosmetics Act, regulating pharmaceutical product registration in India. CDSCO ensures the safety, efficacy and quality of the medical products manufactured, imported, and distributed in the country. CDSCO houses welcoming yet strict Regulatory practices, and thus, an applicant seeking success in India needs to understand the CDSCO registration process and the CDSCO product registration guidelines. Freyr provides a variety of Regulatory affairs services and Regulatory affairs consulting.

  • End-to-end Registration Support
  • Authorized Local Agent Support
  • Manufacturing Site Approval Support
  • Import Registration Support
  • Sample Import License Support
  • Regulatory Affairs Consulting

Know More

Freyr Digital

Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements

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An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information

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Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence Know More

Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.

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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.

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