BIOSIENCE GROUP offers different pharmacovigilance services

12 years in the pharmaceutical market
116 released medicinal products
105 partners

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.


E-mail: [email protected]

Tel (24/7): +38 (068) 667-97-82

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

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+38 050 463 82 66

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