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Learn more about PSMF Manager

Discover how domain experts envisioned and built the PSMF Manager to automate Pharmacovigilance System Master File operations, embedding regulatory compliance and audit readiness into its core.

About PSMF Manager

Developed in-house by PVCON Consulting’s pharmacovigilance experts, in partnership with leading Tech & AI experts and software developers, PSMF Manager revolutionizes the Pharmacovigilance System Master File (PSMF) management lifecycle through powerful automation. Say goodbye to endless compliance risks.

Our progressive platform centralizes updates, ensures compliance, and empowers all pharmacovigilance teams to focus on what matters most: patient safety and regulatory excellence.

It bridges the gap between rudimentary manual processes and modern efficiency, streamlining PSMF control across local countries for MAHs and across various MAHs for Service Providers globally.

With cutting-edge AI-driven insights and PVCON's expertise, PSMF Manager's seamless integrations and configurations are effortlessly scalable for organizations of any size, reducing executive burden while maintaining high standards of accuracy and audit-readiness.

PSMF Manager platform preview

Our Mission and Vision

For years, pharmacovigilance teams struggled with manual PSMF management across the organization, often leading to compliance risks and lost time. We believed there had to be a better way of PSMF handling, for the mitigation of inspection findings.

PVCON Consulting and its domain experts got together to automate PSMF management as a result.

We’re just getting started.

Join us in transforming pharmacovigilance - one automated PSMF at a time.

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Why is PSMF Manager different from other tools in the industry

Smart tools designed to simplify PSMF management reduce manual effort and keep your pharmacovigilance teams always audit-ready

Seamless Local PSMF Management with Global PSMF

Maintain all local PSMFs along with the Global PSMF in a single tool

Managing affiliate PSMFs in a central platform with effortless data mapping avoids redundancies and duplication across PSMFs, enabling sync with global PSMF in real time

AI simplifies Change Reviews and Annex I maintenance

AI-empowered reviews and change log entries

Review and assess changes for factual accuracy, internal alignment and consistency with regulations and auto-entered details within Change Logs through AI capabilities.

Get Started with PSMF Manager Now!

PSMF Manager is a SaaS web-based tool: an automated compliance solution that helps various-sized Pharmacovigilance teams without exhausting disk-space. Watch Video to know more about PSMF Manager

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