Readiness
COMPLIANCE
COMPLIANCE
Prepare with Confidence. Perform with Clarity.
This programme helps teams move from reactive to proactive inspection readiness, particularly in the field of pharmacovigilance. We assess your current systems, identify gaps, and guide your team through a structured, strategic preparation process.
Key Deliverables:
- End-to-end inspection readiness and due diligence assessments
- Gap analysis and system maturity scoring
- Mock inspections and team coaching
- Strategic planning for MHRA, EMA, FDA inspections
Ideal For:
- Teams preparing for first-time or repeat inspections or merger and acquisitions
- Organisations recovering from findings or CAPAs
- PV leaders seeking clarity on system performance
COMPLIANCE
COMPLIANCE
COMPLIANCE
Design Systems for Pharmacovigilance That Work Now and Later.
We help you build and optimize pharmacovigilance and quality systems that are not only compliant but also practical, scalable, and aligned with your operational goals.
Key Deliverables:
- PV and QA system architecture and documentation
- SOP development, harmonisation, and process mapping
- CAPA system enhancement and audit trail alignment
- Cross-functional QMS integration
Ideal For:
- Organisations scaling operations or entering new markets
- Organisations going through mergers and acquisitions
- Teams with fragmented or legacy systems
- QA leaders seeking harmonisation across functions
STRATEGY
Stay Ahead of Risk. Lead with Strategy.
This long-term support programme focuses on strategic oversight, risk management, and continuous improvement in pharmacovigilance. We help you evolve your systems while maintaining compliance and operational control.
Key Deliverables:
- Risk identification, prioritisation, and mitigation planning
- Change management and system evolution strategy
- Strategic input on compliance projects and governance
- Continuous improvement and regulatory foresight in pharmacovigilance
Ideal For:
- Organisations navigating growth or complexity
- PV and QA teams managing multiple compliance domains
- Leaders seeking sustained strategic support
CAPABILITY
Empower Your Team. Strengthen Your Culture.
We deliver targeted training and coaching in pharmacovigilance to build internal capability, support inspection readiness, and foster a culture of compliance across your organisation.
Key Deliverables:
- PV and QA team training programmes
- Inspection coaching and readiness workshops
- Leadership mentoring and compliance mindset development
- Custom learning plans and post-training support
Ideal For:
- Teams new to pharmacovigilance or QA roles
- Organisations building internal compliance capacity
- Leaders developing future-ready teams