Pharmacovigilance processes (SOPs)

Pharmacovigilance processes should comply with regulatory requirements (such as GVP Modules) through corresponding conception, design and implementation.

We give answers to frequently ask questions about

  • PV-tasks,
  • PV-terms and definitions,
  • links to other areas such as manufacturing, distribution (GDP) or Regulatory Affairs, as well as
  • uptodateness and completeness.

and support you with

  • SOP preparation,
  • review, assessment and update of SOPs,
  • planning and completion of underlying PV processes, 
  • integration in your Quality Managment system,
  • establishment of interfaces with other areas (GMP, GCP, GDP, Regulatory Affairs),
  • effective training.

We further give advice and implement solutions if

  • oversight and links between PV-processes are missing,
  • important PV processes are not described,
  • PV SOPs are physically available, but do not reflect reality,
  • appropriate communication and training is missing,
  • PV SOPs are not updated in time or
  • employees do not work with the current version.

CSO Pharma is your experienced partner for reliable implementation.

Please feel free to contact us for a personal consulting. We are looking forward to your enquiry.

Audits

Pharmaceutical companies are regulatory obliged to ensure internal and compliance of contracted partner through audits >>

PV training

CSO Pharma actively supports you with trainings on Pharmacovigilance. To accomplish more with profound knowledge >>