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 | Mar 10, 2021
Quality Management SOP creation Biomapas skilled professionals meet compliance requirements with local and global legislation and client procedures and support the development of customized Standard Operating Procedures (SOPs) to cover customers’ changing needs....
by Anna Kamocsai | Mar 10, 2021
Medical Writing Standard Responses’ Documents update and/or Creation Biomapas Medical Writing team develops and/or updates Frequently Asked Questions (FAQ) and Standard Responses to medical inquiries. Custom Response Creation Writing custom response documents...
