MONITORING OF LITERATURE
Weekly screening of literature sources for drug safety information. Evaluation of information, submission to authorized bodies.
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Pharmacovigilance Agency
PHARMCOMPLIANCE
PHARMACOVIGILANCE WRITING
Pharmacovigilance system master file – PSMF, periodic safety reports – PSUR/PBRER/DSUR regular and including as per Decision 1583, risk management plans (RMP) in EAEU/EU format and harmonization.
SCREENING OF LEGISLATION
Daily screening of legislation. Providing regular reviews. Preparation of Impact Assessments/gap analysis for each specific client pharmacovigilance system.
ORGANIZATION OF THE SYSTEM
Organization of a pharmacovigilance system from scratch and maintenance of the existing one. Building a quality management system (QMS), writing SOPs and other QMS documents.
OUTSTAFFING AND CONSULTING
Provision of qualified employees – QPPVs, their deputies, contact persons, specialists and managers for pharmacovigilance with 24/7 access. Consulting services.
EDUCATIONAL EVENTS
We provide training in pharmacovigilance, organize workshops and professional development programs. As part of our educational activities, we cooperate with leading universities and scientific organizations.
TOP 6 PHARMACOVIGILANCE SERVICES
We provide a full range of pharmacovigilance services for all subjects of medicines circulation. Here are the most popular ones.
MEDICAL WRITING
MPSF, PUR, PSUR, CT protocol, CT and DCT reports, Investigator Brochure, PRUR
MEDICAL WRITING
PSMF, RMP, PBRER/PSUR, CT Protocol, Clinical/Pre-clinical Overviews, Investigator’s Brochure, DSUR.
AUDITS AND INSPECTIONS
Conducting audits of individual processes and the entire pharmacovigilance system. Preparation for audits and inspections. Accompanying inspections.