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.
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
India is one of the top global Medical Device markets with its significant contribution from device imports. Central Drug Standard Control Organization (CDSCO) regulates medical devices and In-Vitro Diagnostics (IVD) marketed in India. The CDSCO is headed by the Drug Controller General of India (DCGI), and the approval authority is shared between the Central Licensing Authority (CLA) and the State Licensing Authority (SLA). CDSCO is responsible for medical device registration in India.
- Regulatory Intelligence and Due-Diligence Services in India
- Medical Device Classification India and Grouping Strategy
- Indian Authorized Agent (IAA) Representation
- SUGAM Account Creation and Account Management
- Test License for Medical Devices and IVDs
- Import License for Regulated Medical Devices and IVDs
The food industry in India is expected to witness unprecedented growth in the coming years due to many factors such as health consciousness, changes in eating habits, and the rise in demand for a sedentary lifestyle. Food business operators face multiple challenges to obtain the Food Safety and Standards Authority of India (FSSAI) license for food import and food product approval, despite the market growth.
- Food Product Classification
- Formula Review/Ingredients Assessment
- Food Label and Claims Review
- Compliance as per the New Labeling Regulation
- Claims Consultation and Substantiation
- FSSAI License Support
- FSSAI Product-approval Support
India, with the world’s second-largest population, stands as a lucrative market for cosmetic products. In India, the Central Drug Standard Control Organization (CDSCO) regulates beauty, and personal care products under the overarching regulations governed by the Drugs and Cosmetics Act 1940 & Rules 1945 vide Gazette Notification G.S.R 763(E). CDSCO controls the cosmetic registration in India. Manufacturers, their authorized agents, subsidiaries in India, and any other importers can apply for the registration certificate issuance for importing cosmetics in India by uploading necessary documents through SUGAM – an official online portal.
- Cosmetics Classification
- Cosmetic Formulation/Cosmetics Ingredient Review
- Cosmetic Claims Review
- Cosmetic Labeling Requirements
- Label Review as per the Cosmetic Labeling Regulations, Cosmetics Rules 2020, and Legal Metrology Rules
- Dossier Compilation
Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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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.
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.Know More
Our Regional Expertise
We are a global firm and we have local expertise across the following countries.