The QMS underpins the pharmacovigilance system and as such, a good quality management system is critical in order to ensure that compliance is maintained. Panacea can help with providing a review of your existing QMS, or support you with implementing a brand new one. Our in house quality team have experience working with QMS systems within Top 5 pharma companies.
Third Party, Vendor & Risk Assessment
Third party, vendor and Risk Management is a continually changing environment for all companies and Panacea are available to support you in mitigating any potential risks, taking care of ongoing compliance. We have a number of practical solutions to support you with this, with as little or as much support as you need. Our services include the writing of due diligence risk questionnaires, the conduct of independent due diligence audits and the assessment of third party risk so to enable companies to strategically plan for the upcoming audits ahead.
Pharmacovigilance Agreement (PVA) / Safety Data Exchange Agreements (SDEA) – Maintenance and Management
We currently manage and maintain many PVA’s/SDEA’s across a number of clients. We work with our own in-house management tools and procedures in synchrony with other companies’ tools, systems and in-house procedures; we pride ourselves on our flexible approach to managing Pharmacovigilance Agreements and the support that Panacea offers reflects this.
GPvP Auditing & Inspection Readiness
SOP Review, Design, Writing & Implementation
Key Performance Indicators
Quality Review of Pharmacovigilance Documentation
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