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Pharmacovigilance Database

by | 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...

EAEU QPPV Services

by | 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...

PSMF Development and Maintenance

by | 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...

Quality Management

by | 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....

Medical Writing

by | 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...

Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.
Affiliate-Based Outsourcing
CSV For Pharmacovigilance Systems
Early Phase Oncology
Functional Service Provision
M&A Support

Clinical Research

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Regulatory Affairs

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Pharmacovigilance

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Medical Information

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Big Enough To Cover All Your Needs.
Small Enough To Care.

Discover how Biomapas provides all the support to accelerate your clinical trials and optimize your drug development process.

Clinical Research

Reliable support for every phase of your clinical trial, from recruitment to results.

Pharmacovigilance

Flexible safety monitoring to keep your products compliant and trusted.

Regulatory Affairs

Confidently navigate regulatory challenges with expert support.

Medical Information

Clear, accurate medical information 24/7, tailored for global audiences.

Quality Assurance

Export auditors help identify gaps and close them with actionable solutions. 

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