Pharmacovigilance Quality Services

QMS Creation & Review

 

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

 

  • Our Quality function has first-hand experience with Regulatory Authority Inspections. We use this experience to offer clients inspection readiness training, post-inspection assistance and support.

 

  • We perform pharmacovigilance independent audits (remote or in-house) for any scenario; including due diligence, third party PVA/SDEA audit compliance or full Pharmacovigilance service audits whether routine or for-cause.

 

  • Internal reviews/audits are a great way to understand your own company’s compliance and Panacea can support you with this. A great example of this is the review of a specific area such as business continuity to mitigate any perceived risk.

CAPA Management & Assistance

 

  • Our experienced team are able to support both with the creation and implementation and closing of Corrective & Preventative Actions (CAPAs). They have experience in both the creation and management of CAPA response documents. (Whether they stem from a routine audit or Authority Inspection, our team work to ensure that you maintain your positive reputation).
    • CAPA’s can be managed within Panacea as part of the outsourcing of a PV service or SDEA management service and Panacea are compliant in CAPA management, TREND identification/management and Impact analysis review.

 

SOP Review, Design, Writing & Implementation

 

  • Quality & efficiency is our mantra at Panacea and we enjoy helping clients with designing, drafting and implementing practical Standard Operating Procedures (SOPs), LWP (Local working practices) and flow charts.
    • We have supported companies by performing GAP analysis reviews of procedures, in order to ensure compliance.
    • We’re also able to support a review of Standard Operating Procedures, where we can suggest procedural updates and process improvements. Cross check your PSMF Annex E determine any potential GAP’s.  We can do this as part of an internal review and prepare project plans for improvements on your behalf.

 

Pharmacovigilance Training

 

  • Whether you require annual, or perhaps some ad-hoc training, Panacea can provide a tailored solution that meets your needs. Our training can cover general pharmacovigilance, or more focussed training on an individual area – we ensure that you get the outcome and knowledge that you seek.

 

 

Key Performance Indicators

 

  • Our experts are well versed in helping you develop and monitor essential pharmacovigilance KPI’s. We can help you with ensuring that you implement the necessary performance measures, or provide assistance in identifying why underperformance might be happening.

Quality Review of Pharmacovigilance Documentation

 

  • Often we receive requests from clients relating to the review of pharmacovigilance documentation & reports, prior to sending externally. Our experts are well versed in identifying any potential gaps and advising on the best way to closing them.

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