Team

For us joint successful work is not empty words, but long-term experience and knowledge united in common cause.

Each of us is the professional with more than ten-year experience in the sphere of clinical trials. Our ability to work, planing and carring out tasks in time will be your advantage in collaboration with us.

Our activity

Clinical trials — is the scientific activity directed to studying of efficiency and safety both new dosage forms, and drug interaction.

I. Scientific management

  • Development of the plan of researches and necessary documentation.
  • Statistical processing of results of researches.
  • Translation of documents.

II. Management of clinical and preclinical trials

  • Choice of researchers and research cents.
  • Conducting monitoring visits.

III. We provide registration services:

  • Medicines;
  • Products of medical appointment;
  • Dietary supplements to food.

IV. Pharmacovigilance

  • Development of the Master File.
  • Creation and maintenance of SOP (Standard Operational Procedures).
  • Training of employees in bases of pharmacovigilance and SOP.
  • Carrying out audit of system of pharmacovigilance.
  • Generating of reports for regulatory bodies.

V. Development and Implementation of the quality management systems (QMS)

  • Development of documentation of QMS according to company business processes.
  • Carrying out independent audits, maintenance of QMS.

Contact Us

Regulatory authority

Ministry of Health: rosminzdrav.ru

Roszdravnadzor (Federal Service on Surveillance in Healthcare and Social Development): roszdravnadzor.ru

State Register of Medicines: grls.rosminzdrav.ru

© 2020 BIT