Regulatory Analysis

Objective :

Assessment of national regulatory guidelines and procedure assessment for the approval of a client’s therapy

Problem Statement:

A large client based in Europe, involved in Dermatology arena with a market-ready product, aimed to assess the Indian Regulatory Scenario to successfully file the product in CDSCO. They wished to identify the guidelines of approval, assess the documentation needed in India, and need for conducting clinical trials and post-market surveillance processes. The client involved DelveInsight to help them understand the overall regulatory scenario by providing effective and in-depth research into CDSCO’s latest reviews process for approval of pharmaceutical products

Our Methodology:

• Regulatory Guideline Assessment
• Clinical Trial Application Approval Assessment
• Understanding Manufacturing and Import Licensing Process
• Detailing the Post-approval Process

Results:

• Detailed description of the Regulatory Approval Process in India.
• Extensive list of documents needed to apply for clinical trial approval, licensing, and registration of their product.
• Simplified framework of the work with latest timelines of potential approval for the products in India.
• Analysis of all requisite requirements for approval.