PV Quality Management System & SOP Development

PV Quality Management System (PV-QMS) Services

Yashfin’s PV Quality Management System (PV-QMS) services are designed to help organizations establish, implement, and sustain a robust pharmacovigilance-specific quality system aligned with EU GVP and global regulatory expectations.
Our solutions enhance operational visibility, regulatory compliance, and continuous improvement through structured quality oversight and risk-based controls.

PV-QMS establishments
0 +
PSMF Development & Maintenance
Preparation, periodic review, and lifecycle management of PSMF in line with EU GVP Module II requirements.
PSMF Summary
Development of a concise, regulator-ready PSMF Summary suitable for inspections and authority submissions.
Electronic PSMF (e-PSMF) Database
Design and implementation of an electronic PSMF repository enabling Marketing Authorisation Holders (MAHs) to maintain, control, and distribute PSMF documentation securely and efficiently.
Country-Specific PSSF (PV Sub-System File)
Creation and maintenance of local PSSF aligned with national regulatory requirements and local PV operations.
Ongoing Maintenance & Change Management
Regular updates to PSMF/PSSF reflecting organizational, system, vendor, procedural, and regulatory changes—ensuring continuous inspection readiness.

A robust, compliant, and inspection-ready PV system file framework that supports regulatory submissions, authority inspections, and global pharmacovigilance operations.

Pharmacovigilance Services

Contact Us

  • B04-332, Business Center 03, RAKEZ Business Zone-FZ,
    Ras Al Khaimah, UAE
  • +971 55 895 5849
  • info@yashfin.net
    info@yashfinpharma.com

Our Brochures

Explore our Service Prospectus for a clear, easy-to-read overview of all services we offer.

Download Brochure
Characteristics