Pharmacovigilance System Master File (PSMF) Services

A comprehensive and up-to-date Pharmacovigilance System Master File (PSMF) ensures pharmacovigilance compliance. Our services are tailored to handle all aspects of the PSMF, including meticulous authoring, regular reviews, and continual maintenance.

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Understanding the Importance of a PSMF

The PSMF is a detailed account of the pharmacovigilance system for all Marketing Authorization Applications and Holders (MAAs/MAHs). It encompasses critical components such as the Qualified Person for Pharmacovigilance (QPPV), organizational structure, standard operating procedures (SOPs), drug safety data, electronic systems, and quality management and control systems.

Our PSMF Services Offer:

  • Comprehensive PSMF Authoring: Thorough creation and development of the PSMF document aligned with Good Pharmacovigilance Practices (GVP) Module II guidelines.
  • Regular Reviews and Updates: Ensuring the PSMF remains current and accurate, adhering to regulatory standards and guidelines.
  • Annex Maintenance and Preparation: Managing and updating supplementary documents (Annexes) to provide additional comprehensive information as required by Health Authorities.

Understanding PSMF Annexes

The PSMF Annexes (Annex A to I) provide crucial supplementary information, including details about the QPPV, delegated tasks, sources of safety data, pharmacovigilance processes, local pharmacovigilance system performance, quality system, and more.

Local PSMF Support

With our extensive experience and pan-Africa reach, we understand the specific local requirements for the PSMF. We can assist in the preparation and maintenance of both the general PSMF and local PSMF, ensuring compliance with all regional authority standards.

For specific requirements from different countries, refer to our dedicated resources here.

Get tailored PSMF solutions that meet your unique compliance needs and regulatory standards.

For comprehensive support in managing your Pharmacovigilance System Master File, Jeyflex ensures your PSMF remains consistently updated and accurately reflects your current pharmacovigilance system.

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Learn more about how we can help you achieve compliance and success in the pharmaceutical industry.

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Learn more about how we can help you achieve compliance and success in the pharmaceutical industry.

Service Details

Our solutions are tailored to meet your unique needs and requirements, whether you’re a small startup or a large multinational corporation. We offer a range of services, including, consulting, training, and auditing, to help you ensure that you are complying with relevant regulations and laws, and to minimize the risk of non-compliance.

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