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-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.