Registration services

The BGP Litigation Pharmaceuticals and Life Sciences team provides businesses with medicine registration and audit support.

The Practice’s team helps companies abide fully by the regulations governing medicine registration and reregistration, and settle clinical trial organisation matters. The Practice also assists in risk analysis, including of risks associated with putting medicines on the Russian market and medicine circulation.

The Practice provides comprehensive support for businesses at all stages of putting medicines on the market, from analysing the available registration dossier documents and preclinical trials to submitting the registration dossier to the Ministry of Health and obtaining a registration certificate.

We can help with:

  • “Turnkey” medicine registration as per national or supranational procedures (EAEU)
  • Preparation or assessment of available registration dossier documents
  • Organisation of (pre)clinical trials
  • Arrangement of consumer testing of instruction leaflets
  • Entry of pharmaceutical substances onto the register
  • Registration of VED prices
  • Audits (GMP, GDP, quality system), development of documentation