Av Consult Pharm Ltd

AV Consult Pharm is a consulting company in the field of the Regulatory Affairs, Pharmacovigilance, Medical Devices vigilance, Cosmetovigilance, price and reimbursement and any other consultancies for the medicines. Our expertise is based on years of experience with Bulgarian Drug Agency (BDA) and on the expertise of our employees – former experts from the Bulgarian Drug Agency (BDA) so we are confident we can meet your needs. Regulatory activities: We propose an appropriate regulatory strategy based on your dossier assessment and include the necessary preparation of the dossier in accordance with national requirements, submission and follow-up of the procedure and timely communication with the relevant authorities. Pharmacovigilance services- Ensuring QPPV, deputy QPPV and Local Safety Officer with medical education / doctor/- 24/7 contact details of QPPV and deputy QPPV - Local contact QPPV (Bulgaria) and related Pharmacovigilance services to support Marketing Authorisation Holders (MAH) for achieving compliance with EU regulatory requirements (Regulation 1235/2010 and Directive 2010/84/EC) and local obligations to assign a local point of contact for pharmacovigilance for every registered product- Development of a pharmacovigilance system (PSMF, SOPs, WI, log-files, Signal-detection)- EU QPPV services (Registration in the EudraVigilance database, ICSR/SUSAR reporting, XEVMPD - electronic submission of information on medicines)- Collecting, processing and evaluation of ICSRs (Individual Case Safety Report) as well as reporting of serious ADR (Adverse Drug Reaction) to EudraVigilance- Weekly Local and Global (via PubMed) literature screening and follow-up assessment of relevant articles/scientific extracts. Medical review of adverse reactions from cases, incl. writing Narrative and Literature Assessment Report - Pharmacovigilance training of all respective employees within your company