Pharmacovigilance Pharmacovigilance

Mesned Pharmacovigilance Center (MPVC) is the first and only licensed Pharmacovigilance Center in Saudi Arabia and GCC Area that offers a fully compliant and high-quality comprehensive package of Pharmacovigilance services, we are committed to patient safety and is willing and ready to collaborate with clients to meet the increasingly complex regulatory requirements in Pharmacovigilance in KSA and GCC Area. Our full range of services offer flexible technologies, resourcing solutions, effective governance and continuous process improvement from early clinical development to marketed product support, through efficiencies, maintaining quality and adhering to regulations.

 

-These services includes:

  • Provides a Saudi authorized QPPV on behalf of the clients.
  • Provides Software database for converting the ICSRs to E2B(R2) XML form.
  • Evaluation and Validation of PSMF & PSSF.
  • Developing a Completed and compliant Set of Pharmacovigilance SOPs.
  • Evaluation and validation of ICSRs, PSURs, & RMPs.
  • Literature Review for local Saudi journals.
  • Preparation of Pharmacovigilance Quality Management System (QMS).
  • MedDRA Coding and Coding Convention Strategies.

Number one goal of MPVC is to ensure that reporting obligations are in line with SFDA and applicable regulatory guidelines and to help our customers meet the strict regulatory requirements, along with managing the safety and risk-benefit

profile of the products, in order to maximize product potential, whilst ensuring patient safety.