The regulatory landscape in India is complex and dynamic. Over the last few years alone, there have been more than 25 changes that have occurred in local and national regulations related to the conduct of clinical trials. Navigating this landscape can be challenging without understanding the guidelines and laws, having the mechanism to track, anticipate or react to changes and having the credibility and track record necessary to resolve issues quickly. Excel Life Sciences offers you industry-leading regulatory expertise to be your trusted partner in navigating the regulatory process, allowing you to move the development process forward efficiently and without glitches.

From comprehensive regulatory and trial management support for your important study, to simply consulting you on the regulatory environment, ELS can make your foray into India easier, giving you the confidence to move decisively when you are ready. Specifically, ELS can assist you with the following activities:

National Regulatory Services:

• Pre-submission discussions with Drugs Controller Generals Office (DCGI)
• Application for permission to conduct clinical trials for New Drug / Investigational New Drug and determine correct Category Status (Category A or Category B)
• Interactions with the DCGI office and head to resolve questions and submit amendments
• Obtain import/export licenses for CTM & Samples
• Handling of all Customs related issues
• Government fee submissions
• Protocol amendment submissions
• Post regulatory approval compliance

Institutional Review Board / Ethics Committee Services (Sample Only – Not a complete list of services or requirements):

• Protocol with application performa
• Approval of the Head of the Institution
• Informed Consent Process (ICF in regional languages)
• Case Report Forms and Follow- up Cards
• Preclinical animal data , Clinical Trial data & IB
• Regulatory clearances from DCGI/ other Regulatory Bodies
• Financial issues related to PI and institutional payments, patient related expenses, etc.
• Agreement to report SAE to IEC
• Assist the PI in completing 1572