Development of a regulatory strategy and scientific advice in realation to:
  • Registration in Russia and the Eurasian Economical Union (EAEU)
  • Bringing the dossier of the drug registered in Russia in accordance with the requirements of the EAEU, taking into account:
    • Further recognition in other countries of the Union
    • Necessity to align with State Pharmacopeia 14
    • Necessity to undergo GMP inspection
    • Planned variations
Registration in Russia and the EAEU
  • Preparation of documentation in accordance with current requirements and practices:
    • Normative document
    • Summary of product characteristics (SmPC)
    • Patient leaflet. Including validation in respective groups
    • Pharmacovigilance documentation
  • Preparation of dossiers in the CTD format and submission to the Ministry of Health for registration
  • Submission of samples for pharmaceutical expertise
  • Preparation and submission of answers to inquires of the Ministry of Health
Post registration support
  • Confirmation of the State registration of a drug
  • Recognition of registration in Eurasian Economic Union (EAEU)
  • Bringing a Normative document in accordance with State Pharmacopeia 14
  • Submission of variations
  • Writing a periodic report on drug safety
  • Preparation of a document containing the results of monitoring the safety of the medicinal product, with the aim of filing in the dossier to confirm state registration
  • Registration and re-registration of drug prices
GMP inspection
  • Preparation and filing of an application for inspection
  • Consultation on the preparation of a production site for inspection
  • Accompanying the inspectors during the site inspection
  • Preparation and submission of responses to inspection findings
Serialization, Aggregation and Track & Trace
  • Conformity assessment of a production line and software to serialization and aggregation requirements in Russia
  • Consulting
  • Registration in the Authority monitoring system
  • Verification of consistency of information about medical product in state databases
  • Obtaining crypto codes and reporting in the monitoring system
Registration of medical devices, including software, in Russia and the Eurasian Economic Union
  • Advice on the registration of medical devices in the EAEU system
    • Obtaining of the scientific advice from Roszdravnadzor in order to confirm the belonging of the product to medical devices, risk class, registration peculiarities.
  • Preparation of Normative and technical documentation and operational documentation
  • Preparation of regulatory documentation and adaptation of manufacturer's documents in accordance with the local requirements.
  • Obtaining permission to import samples of medical devices and import to Russia
  • Preparation of all necessary documents and organization of technical and toxicological tests in accredited laboratories
  • Organization and management of clinical trials of medical devices
  • Preparation and submission of responses to inquires from Roszdravnadzor at all stages of the registration process
Clinical trials
  • Project management
  • Conducting of clinical trials II-IV phases
  • Medical writing
  • Biostatistics: statistical analyses plan, statistical analyses and report.
  • Audit of vendors and Investigational sites
Business Development – search of the local partners or CMO or new products for the existing portfolio.
Investigational sites