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Integrating Pharmacovigilance System Master File (PSMF) with Global QPPV Services and QPPV Strategies
PSMF Solutions
COD’s comprehensive PSMF Pharmacovigilance services are designed to support pharmaceutical companies in EU and beyond, providing meticulous documentation and management of your Pharmacovigilance System Master File. With years of expertise in PSMF, our team ensures agility and compliance for global operations.
Currently COD is managing 13 PSMFs across the globe.
Our Global PSMF solutions include:
- New PSMF: Comprehensive preparation and ongoing maintenance, ensuring it remains up-to-date and compliant with all relevant regulations
- Periodic Update of Existing PSMF
- Regulatory Submissions: Assistance with regulatory submissions and inspections, providing all necessary documentation and support
- Audit and Gap Analysis: Conducting thorough audits and gap analyses to identify and address any deficiencies in your pharmacovigilance system
Training and Support: Providing training and support to your team to ensure they are fully equipped to manage and maintain the PSMF
Global QPPV Services
Our Global QPPV Services are designed to ensure seamless communication and compliance across diverse regions worldwide.
Our team includes in-house experts and qualified professionals specializing in Pharmacovigilance QPPV roles, such as EUQPPV, UKQPPV/NCP, and an ex-EUQPPV who leads our operations.
Our QPPV Services are responsible for the following pharmacovigilance functions:
- Overseeing safety profile assessments
- Ensuring adherence to Good Pharmacovigilance Practices (GVP)
- Serving as the primary liaison with health authorities
Request for Proposal
Our aim is to establish robust PSMF Pharmacovigilance practices that ensure regulatory compliance and patient safety across all markets. Reach out to us today to benefit from our integrated PSMF and QPPV Services for global compliance.