Pharmacovigilance System Master File

PSMF, a reflection of the organizational PV system

The PSMF plays a pivotal role and requires expert knowledge to meet all of the regulator’s requirements.  Setting up and transitioning to the PSMF is a time-consuming business, as is PSMF maintenance. We can work with client IT platforms or can help find the best IT solution to outsource the whole PSMF to us.

Controlled access to the electronic PSMF would be enabled at the site of the main pharmacovigilance activities in Europe and/or with the QPPV, to enable compliance with a regulatory requirement.

PSMF Management
Summary of PSMF
e-PSMF Database where a MAH can maintain and distribute the entire PSMF electronically
Country-specific PSSF (PV subsystem file)
Summary of PSSF
Maintenance of PSMF / PSSF
Compliance metrics
Personal Care Super Support Guaranteed

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Contact

  • B-04-332, Business Unit-3,
    Ras Al Khaimah, UAE
  • +971558955849
  • info@yashfin.net

Brochures

View our brochure for an easy to read guide on all of the services offer.

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