Strategic Regulatory Partner for Success in India

Greetings from

Pharma Wizard India

Pharma Wizard 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 ā€œlocal to globalā€ journey. At Pharma Wizard 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 in India

The Central Drugs Standard Control Organization (CDSCO) is India’s key health authority under the Drugs and Cosmetics Act, responsible for regulating the registration of pharmaceutical products. CDSCO ensures the safety, efficacy, and quality of all medical products that are manufactured, imported, or distributed within the country.While CDSCO maintains a structured and transparent regulatory framework, the process can still be complex and time-consuming. Success in the Indian market demands a thorough understanding of CDSCO registration processes and product-specific regulatory guidelines.

Pharma Wizard India offers end-to-end Regulatory Affairs services designed to help clients navigate these requirements seamlessly:

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

With deep expertise in Indian Regulatory systems and strong liaison with CDSCO, Pharma Wizard ensures a streamlined path to compliance and market access.

Medicinal Product
India is counted as one of the top global Medical Device markets with its major contribution from device imports. The Central Drug Standard Control Organization (CDSCO) regulates medical devices and In-Vitro Diagnostics (IVD) marketed in India. The CDSCO is headed by Drug Controller General of India (DCGI) and the approval authority is shared between Center Licensing Authority (CLA) and the State Licensing Authority (SLA). India CDSCO Medical Device Registration requires abiding by multiple regulations pertaining to device classification and patient safety standards.
Medical Device

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
Food and Food Supplement

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
Cosmetics

Looking for Regulatory Support in India

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