GOOD PHARMACOVIGILANCE PRACTICE (GVP)

At SPGL, we are deeply committed to enhancing the value of the GVP services we offer our clients. We are continually evolving our services to meet the demands of global regulatory standards, industry shifts and the specific requirements of our clients, ensuring that we maintain our position as a global frontrunner in GVP consultancy.

We are convinced that SPGL stands alone in its ability to guide our clients from the initial concept through to the final delivery, ensuring that their GVP compliance efforts are not just meeting but setting industry benchmarks. Beyond our comprehensive full-system GVP auditing services, SPGL uniquely provides bespoke GVP auditing solutions. These can be tailored to address one or multiple areas on a worldwide scale, offering our clients the chance to concentrate their compliance efforts precisely where they have the most impact.

Our SPGL GVP team is not just experienced, it is a carefully assembled group of experts with significant exposure to industry inspections and auditing. This strategic composition guarantees that our clients benefit from unparalleled expertise in both GVP systems and process audits.

Our range of GVP services encompass:

PV system and process audits (Pre & Post marketing audits)

  • Pharmacovigilance System Master File (PSMF)
  • Qualified Person for PV (QPPV)/Local Responsible Person
  • Global Safety Database
  • Case Management (SUSAR/ICSR)
  • Aggregate Reporting (PSUR/DSUR)
  • Risk management
  • Signal management
  • Medical coding
  • Product labelling
  • Regulatory Intelligence
  • Post authorisation safety studies (PASS)
  • Patient Support Program/Non-Interventional Program
  • Quality management system
  • Vendor management and Marketing Authorisation Holder (MAH) oversight
  • Audit strategy planning and management

Third party audits

  • Commercial partners
    • Marketing partners
    • Distributors
    • Licence partners
  • Service providers/vendors
    • PV
    • Medical Information
    • Call Centres
    • Market Research Programs
    • Patient Support Programs
    • Pregnancy Prevention Programs
    • Compassionate Use Programs

Consultancy

  • Risk based audit planning
  • Audit program management
  • Inspection Readiness training
  • Mock inspection
  • GAP analysis
  • CAPA/EC management
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