We can offer Third Party audit service and consultancy.Our Regulatory Affair and Technical Writing consultancy services  are as follows-

  • Establishment licence and Site License in Canada/USA
  • Project management of Regulatory Affairs activities
  • Prepare and submit medicinal product application for marketing authorization in Canada, USA, Europe and emerging market
  • Test specification preparation, Certificate of Analysis preparation
  • SOPs, Protocols, summary report preparation, Trending of EM for manufacturing premises
  • Analytical method development protocol writing,  analytical method validation protocol writing