PV Set-Up & PSMF Alchemy

Building Robust Pharmacovigilance Systems for Compliance and Safety

A well-established Pharmacovigilance system, including a comprehensive Pharmacovigilance System Master File (PSMF), is essential for regulatory approval and ongoing compliance.

Alchemy’s PV Set-Up & PSMF Services: End-to-End Compliance Solutions

Alchemy assists in setting up end-to-end PV systems, including the development and maintenance of PSMFs that align with global regulatory requirements.

PV System Design

Establishing PV systems tailored to product lifecycle and region.

PSMF Development & Maintenance

Compliant Pharmacovigilance System Master File setup and updates.

SOP Development & Compliance

End-to-end creation of SOPs for global PV activities.

Inspection Readiness Assurance

System checks and audits to ensure GVP alignment.

Why Choose Alchemy for PV Set-Up & PSMF?

Global PV System Expertise – Proven capability in implementing end-to-end pharmacovigilance systems globally.
Tailored PSMF Solutions – Customized Pharmacovigilance System Master File creation and ongoing maintenance.
Regulatory Compliance – Adherence to EMA, MHRA, USFDA, and other global authority standards.
Operational Excellence – Robust frameworks that ensure safety data management and audit readiness.

100

Setups Completed

PSMFs authored

Audit Success

SOPs implemented

Testimonials

Voices of Trust

“Alchemy set up our PV system from scratch—including SOPs, workflows, and PSMF—within a month.”

Biocentra

Regulatory Affairs Manager

“Their customized PSMF templates saved us time and passed our first MHRA inspection.”

Credora Pharmaceuticals

PV Compliance Lead

“We felt confident knowing our PV infrastructure was aligned with EU GVP expectations.”

Neureva Bio

Senior Risk Management Officer

“Thanks to Alchemy, we passed our PSMF audit with zero findings.”

Virexa Pharma

Safety Compliance Head

Discuss Your PV System Requirements

Discuss with Experts

Request a Quote for PV Set-Up & PSMF

Request a Quote