Regulatory Affairs

You say we'll do it!

  • Preparation and compiling the dossier based on quality, safety & efficacy information.
  • Helping in assisting response required to submit HA.
  • Assisting in preparation of variation package.
  • Assisting in identifying gaps in MAH submission documents & current documents.
  • Patient information leaflet
  •  Clinical literature & non clinical literature review and compilation.
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INNOVATION IN EVERY STEP!

 “There is a spiritual aspect to our lives — when we give, we receive — when a business does something good for somebody, that somebody feels good about them!” – Ben Cohen, Co-Founder Ben & Jerry’s