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Our Presence

USA | India

Email Us

info@atvigilx.com

PSMF setup & maintenance

PSMF setup & maintenance ensures regulatory compliance by establishing & managing Pharmacovigilance System Master Files with meticulous attention to detail. At Atvigilx, our dedicated team handles the setup & ongoing maintenance of PSMFs, ensuring alignment with regulatory requirements. We conduct thorough reviews, updates, & audits to ensure accuracy & completeness. Additionally, we provide comprehensive support, including staff training & SOP development, to enhance system effectiveness.

PSMF Compilation and Maintenance Support

Comprehensive support for compiling and maintaining the Pharmacovigilance System Master File (PSMF), ensuring compliance and up-to-date documentation.
Initial compilation of PSMF
Regular updates and reviews
Compliance with regulatory requirements
Detailed documentation and record-keeping
PSMF Setup & Maintenance
Up-To-Date Information

Up-To-Date Information

Continuous oversight and upkeep ensure an audit/inspection-ready PSMF, providing the QPPV and authorities with current, accurate information.
Access

Access to the PSMF

Immediate access to the PSMF is available upon request by competent authorities, either at the specified PSMF location or the QPPV site, ensuring compliance.
Change Control Process

Change Control Process

Actively solicit all changes, including organizational, contractual, mergers, & transfers, from the MAH to ensure robust change control for the PSMF information.