Pharmacovigilance consultancy
Independent advice on PV strategy, safety oversight and decision-making. Help interpret emerging safety information, prioritise concerns and define a proportionate, well-documented approach.
Areas of support
The right expertise.
Exactly where it’s needed.
Independent pharmacovigilance consultancy for teams seeking clear advice, an experienced second opinion and practical solutions across clinical development and post-marketing safety.
Projects & strategic support
Experienced guidance on safety projects and key deliverables, including signal detection and management, RMPs, DSURs and other periodic reports. Support planning, critical review and clear regulatory safety narratives.
Problem solving
A fresh, experienced perspective on complex PV questions, safety data inconsistencies and difficult cases. Clarify the issue, assess options and recommend practical, risk-based next steps.
Medical & scientific advice
Medical review and scientific input on safety information, case narratives, causality, seriousness and expectedness. Strengthen the clinical interpretation and consistency of safety assessments.
Clinical development & safety
Advice across Phase I–IV clinical development and post-marketing safety. Review IBs, protocols, patient profiles and safety data; help teams resolve discrepancies and align safety considerations.
Quality, compliance & process improvement
Independent review of PV processes, SOPs and work instructions, with recommendations to improve clarity, compliance and efficiency. Support vendor oversight, regulatory responses and quality-related decisions.