Pharmacovigilance audits (PV audits) and inspection support

Pharmacovigilance audits (PV audits)
and inspection support

BlueReg understands the requirements of the health authorities when it comes to Pharmacovigilance audits and what to expect, as such we can provide you with a complete audit preparation package which we can tailor to your needs, including:

  • SOP reviewing/writing
  • PSMF writing
  • CAPA review
  • Setting up the Quality Management System (QMS)
  • Conducting audits of sites (internal/third party)
  • Conducting mock audits
  • Providing support on-site during the audit
  • Pre-audit training to staff
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