Regulatory Approval Services

To achieve commercial success, you need to connect successful approved drugs and mid-to-late stage pipeline drugs to the underlying trial information. You’ll also want to focus in on the best trial designs and comparator arms that have met with success across target markets. What we offer Our solutions give you the tools and intelligence to quickly build up a landscape of approved and pipeline drugs for a disease of interest. We cover where drugs have been approved or are in development, and timeline projections for clinical trials and time to regulatory approvals.  You’ll also be able to find comprehensive, accurate regulatory information on devices/diagnostics, particularly for FDA and CE Mark approvals. Plus, you can save time filtering information by mechanism of action or drug class. How it helps We’ll help you: Stay up to date with new regulatory trends/changes in pharma and medtech Anticipate label claims of your competitors and ensure your product has a strong and promising future in the market Learn from the pitfalls of terminated trials for similar drugs  Understand successful (and unsuccessful) strategies to achieve priority regulatory designations, that you can incorporate into your own development plans        Tap into the industry’s top analysts to help with your research needs

The Indian medical regulatory system has become more stringent in recent years. In past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered under Medical Devices Rules, 2017   Medical Device Rules, 2017 came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO)   The Central Drugs Standard Control Organization (CDSCO) is a regulatory body   that lays down stringent standards that any drug, medical devices, diagnostic kits, cosmetics, biologicals and vaccines being introduced into the country must meet before being sold in the market.

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