Home

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

Overview of the Indian
Regulatory Landscape

Central Drugs Standard Control Organization (CDSCO) is an Indian Health Authority prevailing under the Drugs and Cosmetics Act. CDSCO has six (06) zonal offices, four (04) sub-zonal offices, 13 port offices and seven (07) laboratories under its control. The Drugs & Cosmetics Act, 1940, has entrusted various responsibilities to central and state regulators to regulate drugs & cosmetics. Significant functions of CDSCO are Regulatory control over the import of medicines, approval of specific licenses, approval of new medicines, clinical trials, Subsequent New Drugs (SND), Fixed-Dose Combinations (FDC) & Investigational New Drug (IND). Central License Approving Authority (CLAA), Medica Device Classification, devices meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) are exercised by the CDSCO, DCGI headquarters. CDSCO is responsible for pharmaceutical product registration in India. The Agency is constantly thriving to bring out transparency, accountability, and uniformity in its services to ensure the 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, 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

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
Know More

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
Know More

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
Know More

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.

Know More

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

CLICK HERE TO VIEW IN MAPS

Quick Inquiry
x