Registration services

ARS has significant experience in providing the following services:

  • Drugs registration
  • Botanical medicines registration
  • Dietary supplement registration
  • Maximum sale price registration and re-registration
  • Preparation and submission of documents required for GMP certificate obtainment
  • Conducting independent inspections of drug manufacturing and/or preparation for the audit
  • Bringing registration dossiers into conformity to the EEU requirements
  • Making amendments to the document of registered drugs
  • Confirmation of state registration (renewal of state registration)
  • Technical dossier conversion into XML format (electronic dossier)
  • Other consulting services on regulatory and intellectual issues in the pharmaceutical field

Our competitive advantages:

       11     years of experience in the Russian Federation

       400+ registered drugs

       50 +  drugs on-going

       20     submitted and accepted by the authorized federal body dossiers in accordance with the EEU requirements