Your Trusted Partners for Quality Assurance and Regulatory Services…
WHY ARE WE HERE?
YOUR TRUSTED PARTNERS FOR GXP AUDITING SERVICES
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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.
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
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