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Regulatory solutions & services for Life Sciences industry

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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
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Greetings from Freyr India

Freyr is one of the largest global, Regulatory-focused solutions and services companies. We support Life Sciences companies entering Indian Pharmaceutical market in their entire Regulatory value chain, ranging from Regulatory strategy, market intelligence, local representation, and post-approval product maintenance functions.

The Central Drugs Standard Control Organization (CDSCO) is the Indian Health Authority that regulates drugs, medical devices, and cosmetic products. Food products are regulated by the Food Safety and Standards Authority of India (FSSAI). With our on-ground team of Indian Regulatory experts, we help you obtain approval for your products from the CDSCO and ensure a smooth market entry in India.

 

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
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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
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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
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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
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Freyr Digital

Freyr SUBMIT PRO
Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
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Freyr IMPACT
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Freyr Label 360
Freyr Label 360 The Real-time is Now REAL Content To Carton.
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Freyr PRISM
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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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries. Click to know more.

Location

Level 4, Building No. H-08,
Phoenix SEZ, HITEC City 2, Gachibowli,
Hyderabad – 500081

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