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Contact info

Marcel Horlings
T: +31 (0)71 524 40 00
E: mail@vigilex.com

Safety Procedures

A dedicated team is focussed on the writing of global, regional and local Standard Operating Procedures (SOPs), as well as working instructions and manuals such as data entry and MedDRA coding manuals.

The writing process involves close consultation with the client, as needed, to ensure construction of an appropriate and tailored SOP system.

Vigilex has also expertise in creating and/or review of the Pharmacovigilance System Master File (PSMF) and the transfer of the Detailed Description of the Pharmacovigilance System (DDPS) to the  PSMF.