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.
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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