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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...

Pharmacovigilance Audits

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...

Pharmacovigilance

Pharmacovigilance  A partner that combines local expertise with a global reach to meet compliance requirements. Safety doesn’t happen by chance. It happens by vigilance. A solid extension of your pharma or biotech safety team for both full a PV system and a...

Regulatory Intelligence

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...

Pharmacovigilance System Set-Up

Pharmacovigilance System Set-Up & QPPV Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System We...

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