Pharmacovigilance Services
OUR SERVICES:

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.
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