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Local Regulatory Affairs Support

Home 9 Page Category: Regulatory Local Regulatory Affairs Support Insource our Local Regulatory experts. When and where you need them the most. Product lifecycle management is a challenge for Marketing Authorization Holders in a highly competitive market and a...

Safety Database – Veeva Vault

A modern solution in the cloud Vault Safety is an efficient and modern drug safety solution built for today’s regulations and best practices. Biomapas Pharmacovigilance specialists utilize this powerful tool for collecting, managing, and providing real-time...

Pharmacovigilance Database

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...

EAEU QPPV Services

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...

PSMF Development and Maintenance

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...

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Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

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