Have you had an adverse regulatory finding? Have you identified serious issues internally? Serious problems can occur and it's critical that you ensure you have properly managed the remediation of the problem. Often, an independent review of your systems and CAPA can be valuable.

What We Offer

We can offer a unique combination of MHRA regulatory experience, along with a practical, pragmatic industry background in order to help you design robust, cost-effective and practical solutions. We can give you an independent view on how to address your issues.

Adverse Inspection Findings

​Help to manage serious regulatory inspection findings. independent review of CAPA and action plans.

  • ​Help in designing responses
  • ​Independent review and advice
  • Advice on how to design responses in line with regulatory expectations

Significant Risks

Assistance in managing risks identified internally or via self-inspection.

  • Independent review of risk
  • Help in understanding significance of issue
  • Practical advice on how to remedy & how to present at inspection