Drug Registration

We offer you full service for the regulatory transition of your product from submission to registration. Drug registration is a lengthy, complicated and expensive process that requires highly experienced knowledge to ensure smooth and cost-effectiveness development as well as forward –looking approach to minimize unexpected delays.

A-Pharma expert team copes with all the related procedures such as:

  • obtaining management and policy support
  • review of enabling legislation and regulations
  • identification of needs, definition of enabling objectives, and priorities establishing
  • review of forms, procedures, and correspondence
  • update of forms and certificates as required
  • preparation of data and deciding how to handle data entry
  • beginning of computerization
  • negotiation with the State Institute for Drug Control
  • application to the the State Institute for Drug Control
  • eCTD
Drug registration
  • Drug registration