Good Pharmacovigilance Practice (GVP) Audits
At ADAMAS, we are continuing to build on our reputation as the leading international service provider for the provision of GVP full system and process audits worldwide.
Pre and Post Marketing Full System GVP Audits
Tailored GVP Process Audits
Mock GVP Inspections & Inspection Readiness
Find out how ADAMAS Consulting can help with your next project
Recent examples of our work:
Management and delivery of global GVP audit programmes
Consultancy for global risk-based GVP audit strategy and planning
Pre-Inspection gap analysis and Inspection readiness
Post-Inspection CAPA formulation and response
At ADAMAS we place significant emphasis on adding value to the GVP services we provide.
Our in-house GVP consultancy team has been developed based on the principle of significant industry, regulatory and international experience and includes both former inspectors and industry experts.
This ensures that we have an understanding of the regulatory requirements, and that we can deliver first-hand experience on Competent Authority expectations and how GVP requirements are pragmatically applied in industry today.
This year alone, ADAMAS conducted GVP audits in over fifty countries and has successfully managed global headquarter, affiliate, business partner and service provider audit programmes for several pharmaceutical organisations, ranging from virtual biotechnology companies to the top 10 global pharmaceutical companies.
GVP Audits
- System Audits
- Inspection Readiness
- Mock Inspections
Pharmacovigilance Programme Management
- Reference Safety Information
- OCSR Case Processing
- Aggregate Reporting
- Audit Strategy/Planning
- Risk Management Planning
- Signal Detection
- Pharmacovigilance System Master File
- Patient Support Programmes/Non-interventional Programmes (NIP)
- Marketing Authorisation Holder Oversight
- Third Party Service Providers/Commercial Partners
“I just wanted to say “thank you” for today’s debrief, it’s the best debrief I’ve participated in during my tenure at the company. We really appreciate your thoroughness, expertise and support.”
“The Mock inspection was ‘perfect’ a good experience that helped us prepare for the ‘real thing’. It was as real as possible.”
Contact Us
If you've got any questions or queries about our services, careers, or training, please get in touch.
We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.
