Regulatory Affairs

  • To achieve the regulatory goal, we can suggest a concrete regulatory strategy to give you a competitive advantage.
  • Provide detailed feasibility before study execution to get real-time information and expected timelines.
  • Preparation & submission of regulatory documents for obtaining-
  • Approval to conduct a clinical trial in India
  • Approval to import Investigational Products
  • Central Bureau of Narcotics (CBN) and State FDA permit to import Narcotic and Psychotropic substances
  • Liaising and Obtaining registration documents in the interest of clients
  • Continuous follow-up post submission with regulatory authorities
  • Safety reporting
  • Preparation of regulatory submissions in CTD and eCTD format
  • Preparation of summaries required for generic submission
  • Executing regulatory submission
  • Responding to the health authorities’ queries during the approval phases of the product