Webinar - The new QMS Normal Post COVID19 for the Pharma, Life Sciences & Medical Device Companies

Regulatory Services

Computer System Validation

CRQA provide wide range of solutions for pharma and clinical research regulatory issues. Our team is well equipped to provide turnkey solutions for the regulatory issues in India for drugs and devices. Some of our key services are:

  • Regulatory feasibility studies, market research and market entry strategy for the drugs and devices.
  • Drug & medical device registration.
  • Import and manufacturing permissions
  • Laboratory testing services approvals and compliances.
  • Clinical Trial approvals from Drugs Controller General India
  • Approvals to import clinical trial supplies and material from Drugs Controller General India.
  • Approvals to export clinical trials related human biological samples for their analysis.
  • REGULATORY SERVICES :

    We provide regulatory services to facilitate all stages (Phases I-IV) of drug development. Our ability to assist sponsors obtain regulatory approvals is supported by a deep understanding of, and experience in dealing with the complexities of the Indian regulations. We provide feasibility analysis of foreign products with a way forward and strategy planning of how to apply for regulatory approvals in the fastest possible time.

    THE AREAS THAT WE CAN ASSIST YOU ARE

  • New Chemical Entity
  • Biologicals
  • Medical devices
  • Dietary Supplements
  • SERVICES

  • Regulatory approvals for Phases I-IV clinical trials including new indications and special population studies
  • Regulatory approvals for conducting BA/BE studies
  • Safety reporting
  • Product registration for marketing approval
  • Approval for import /export of supplies
  • For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in



    Webinar - The new QMS Normal Post COVID19 for the Pharma, Life Sciences & Medical Device Companies