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REGULATORY

The regulatory landscape in India is complex and dynamic. Over the last few years, there have been more than 25 changes in local and national regulations related to the conduct of clinical trials.

Navigating this landscape can be challenging without fully understanding the guidelines and laws. ELS has the mechanism to track, anticipate or react to changes and the credibility necessary to resolve issues quickly. ELS offers you industry-leading regulatory expertise to be your trusted partner in navigating the regulatory process. This allows our sponsors to move the development process forward more efficiently.

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 a successful one. Specifically, ELS can assist you with the following activities:

National Regulatory Services:

  • Pre-submission discussions with Drug Controller General of India’s (DCGI) office.
  • Regulatory clearances from DCGI/ other regulatory bodies.
  • Prepare strategy and execute SEC meeting.
  • Preparing eDossiers for registration of devices and drugs.
  • Application for permission to conduct clinical trials for New/Investigational Drug.
  • New Drug and determine & recommend appropriate strategy.
  • Application for permission to import of New Drug for sale in India.
  • Interactions with the DCGI office to resolve questions and submit amendments.
  • Obtain import licenses for CTS.
  • Handling of all customs related issues.
  • Study amendment submissions as per D & C Act, Rules.
  • Post regulatory approval compliance.

Key Institutional Ethics Committee 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 data & clinical trial data.
  • Financial issues related to PI and institutional payments, patient related expenses, etc.
  • Agreement to report SAE to IEC.
  • Safety reporting of SAE and CIOMS to IEC and DCGI.