About service

BIOSCIENCE GROUP offers services for the implementation and maintenance of both the entire pharmacovigilance system and its individual elements.

BIOSIENCE GROUP offers the following pharmacovigilance services:

Implementation of the pharmacovigilance system at all stages of the life cycle of a medicinal product;
Provision of services QPPV/CPPV;
Development of a pharmacovigilance system master file (PSMF);
Development of risk management plans (RMP), including measures to minimize risks;
Development of addendum to the clinical overview (ACO);
Development of periodic safety update reports (PSUR);
Development of summary data on medicinal product safety;
Development of contracts, plans, schedules and other documents of the pharmacovigilance system;
Continuous monitoring of the safety profile of medicinal products and the system as a whole;
Quality management of the pharmacovigilance system, including the development of standard operating procedures;
Providing training on pharmacovigilance;
Organization of the collection and management of spontaneous messages and signals, including local monitoring of literature;
Communication with regulatory authorities on pharmacovigilance issues.

CONTACT DETAILS OF RESPONSIBLE PERSON FOR PHARMACOVIGILANCE:

Ukraine, 03126, Kyiv, blvd. Vaclav Gavel, 40A, office 22

Pharmacovigilance