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.