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Regulatory Services in India

Regulatory Compliance Experts in India

The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority (NRA) of India that is responsible for the safety, efficacy, quality, and control of conducting clinical trials, implementing drug standards, controlling the quality of imported drugs and for coordinating State Drugs Control Organizations activities. It falls under the Directorate General of Health Services under the Ministry of Health and Family Welfare as part of the Indian Government. CDSCO aims to provide transparency, accountability, and uniformity in its drug evaluation services to guarantee the safety, efficacy, and quality of medications that are manufactured, imported, and sold in the country. Drugs and cosmetics are regulated by central and regional authorities under the Drugs & Cosmetics Act of 1940 and the rules of 1945. The State Drug Regulatory Authorities (SDRAs) exist at state levels for regional drug regulation and are often conjoined with the FDA of the state which often leads to complications in differentiating regulatory affairs Service responsibilities and can contribute to hinderance of the administration processes at early stages. Additionally, the stringency of the requirements set by the CDSCO can pose challenges for manufacturers that wish to obtain marketing authorizations for their medicinal product, for the Indian market.

As a leading global contender, DDReg’s regulatory services in India provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings and market authorizations.

Our Regulatory Consulting Services In India Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regulatory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • API/DMF
  • ICSR Processing and Submission
  • Risk Management
  • Aggregate Reports
  • Signal Management
  • QPPV Services
  • Bio Waiver Justifications
  • Clinical & Non-Clinical Experts Reports
  • IPR Support, including Worldwide Patent Status and Patent Reviews
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