PharmRegS offers a comprehensive range of pharmacovigilance services in the Eurasian Economic Union, in accordance with the requirements of Federal Law No. 61 and Good Pharmacovigilance Practices of the EAEU countries.
Designation of an authorized person for pharmacovigilance in the EAEU and their deputy.
Preparation and maintenance of pharmacovigilance systems and internal quality control.
Independent audit of the pharmacovigilance system at the marketing authorization holder's company.
Creation and validation of the Pharmacovigilance Master File in the marketing authorization holder's company.
Development and validation of a Risk Management Plan and a List of Key Data for the medicinal product.
Post-marketing pharmacovigilance: Monitoring of adverse drug reactions (ADRs) and the effectiveness of medicinal products.
Preparation, validation, and submission of the Periodic Safety Update Report (PSUR) / Development Safety Update Report (DSUR).
Information gathering from open sources (literature, internet, databases, etc.).
Conducting training sessions.
Development and implementation of Standard Operating Procedures (SOPs).
Support for clinical trials regarding pharmacovigilance.
Processing safety data obtained during clinical trials and compiling the safety section of the final report.
Moscow, 117105, Varshavskoye Highway, Building 1, Block 6.