by Anna Kamocsai | Mar 10, 2021
Pharmacovigilance Database Biomapas pharmacovigilance and clinical safety management services are supported by a fully E2B and CFR21 Part 11 compliant database. Our safety database has an integrated submission management tool for direct submissions, complex search...
by Anna Kamocsai | Mar 10, 2021
EAEU QPPV Services EAEU QPPV Services According to the EAEU GVP, each MAH should appoint and have at its permanent disposal a qualified person responsible for pharmacovigilance (QPPV) in the member-states. One of the challenging legislative aspects of...
by Anna Kamocsai | Mar 10, 2021
PSMF Development & Maintenance A Pharmacovigilance System Master File (PSMF) summarizes your pharmacovigilance (PV) system and is a critical document for any Marketing Authorization Holder. To comply with EU PV legislation requirements, all MAHs and MAH applicants...
by Anna Kamocsai | Feb 10, 2021
Pharmacovigilance Audits Biomapas offers Pharmacovigilance (PV) audits to evaluate the appropriateness and effectiveness of your pharmacovigilance (PV) system. Our well-trained auditors with a proven track record keep an objective, independent mindset when inspecting...
by Anna Kamocsai | Jan 5, 2021
Home 9 Page Category: Regulatory ( Page 2 ) Regulatory Intelligence Biomapas’ regulatory intelligence services allow you to formulate a feasible drug development, clinical, and commercialization strategy. Our years of experience in monitoring, obtaining and...