Pharmacovigilance

ALPHALEK’s professionals have the appropriate qualification and adequate knowledge of pharmacovigilance activities. These skills enable us to be a pharmacovigilance contact partner in the Republic of Belarus for many European pharmaceutical companies.

Pharmaceutical regulations bind manufacturers of drug products to ensure a continuous operation of system of adverse reactions monitoring (Pharmacovigilance).

OUR SERVICES:

• Obtaining and handing over of reports on adverse events identified in the territory of Belarus, including notifications from end-users, physicians, reports from non-interventional study and literature and so on
• Submission of reports on adverse events and safety reports to regulatory authorities
• Search of communications on identified adverse reactions in specialized literary sources and preparation of correspondent reports
• Intercommunication with regulatory authorities in the matter of pharmacovigilance