Pharmacovigilance system master file (PSMF) services

As the EU/PV legislation became fully effective in July 2015, Ashfield Pharmacovigilance can help navigate the sometimes complex requirements associated with this new directive. Our medical writing and regulatory team prepares numerous documents each year, including PSMF and associated annexes. This group of healthcare and regulatory professionals produces comprehensive reports and monitors updates to ensure compliance with changing regulatory requirements. Our experts can help update items from the Detailed Description of Pharmacovigilance Services into the new ‘living document’ format, while ensuring frequent communication with clients to keep annexes up-to-date.

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PSMF services include:

  • Creation

  • DDPS to PSMF transition

  • Managing PSMF updates

  • Template and SOP development

  • Consultancy and training

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