Our team prepares documentation on pharmacovigilance, registration and clinical trials in the format required by the legislation of the Eurasian Economic Union / European Union, as well as their mutual harmonization.
We are preparing the following documents:
- Pharmacovigilance System Master File (PSMF)
- Periodic Safety Reports (PSRs) regular and pursuant to Regulation No. 1583
- Risk Management Plans (RMPs)
- Standard operating procedures (SOPs), quality manuals and other quality management system (QMS) documents
- Safety data exchange agreements with business partners
- Resource package for safety communication to regulators / healthcare professionals / patients as part of the safety signal management process
- Clinical study protocol and report
- Clinical and non-clinical study overviews
- Brochure Investigator
- Report on the safety of the drug in development