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Freyr Expertise

  • End-to-end Registration Support 
  • Authorized Local Agent Support 
  • Manufacturing Site Approval Support
  • Import Registration Support
  • 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
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Overview of the Indian
Regulatory Landscape

Central Drugs Standard Control Organization (CDSCO) is an India health authority prevailing under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control. The Drugs & Cosmetics Act, 1940, has entrusted various responsibilities to central and state regulators for regulation of drugs & cosmetics. Major functions of CDSCO are Regulatory control over the import of drugs, approval of certain licenses, approval of new drugs, clinical trials, Subsequent New Drug (SND), Fixed Dose Combinations (FDC) & Investigational New Drug (IND). Central License Approving Authority (CLAA), Medical devices meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) is exercised by the CDSCO, DCGI headquarters. CDSCO is constantly thriving to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical products manufactured, imported and distributed in the country.

 

Industries We Serve

Central Drugs Standard Control Organization (CDSCO) is an Indian health authority under the Drugs and Cosmetics Act, which regulates the medicinal products in India. CDSCO is responsible to ensure safety, efficacy and quality of the medical products manufactured, imported and distributed in the country. CDSCO houses a welcoming yet strict Regulatory practices, and thus, an applicant with a proper Regulatory guidance can succeed in India.

  • 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 major 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). 

  • Regulatory Intelligence and Due-Diligence services in India 
  • Medical Device Classification 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 the eating habits and the rise in demand for sedentary lifestyle. Despite the market growth, 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. 

  • 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). Manufacturers, their authorized agents and subsidiaries in India and any other importers can apply for the issuance of a registration certificate for importing cosmetics in India by uploading necessary documents through the official online portal, known as SUGAM. 

  • Cosmetics Classification
  • Cosmetic Formulation/Cosmetics Ingredient Review
  • Cosmetic Claims Review
  • Label Review as per the Cosmetic Labeling Regulations, Cosmetics Rules 2020 and Legal Metrology Rules 
  • Dossier Compilation
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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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