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.
Ian Ramsay has been deemed eligible by the MHRA to act as a Compliance Monitor (CM) in MHRA's pilot compliance monitor programme for GMP/GDP remediation supervision activities.
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
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
RamsayPharma have regulatory experience in dealing with and resolving serious non-compliance cases. We know what the regulators want and how best to avoid issues.
RamsayPharma have extensive experience in helping companies remediate complex compliance issues. We have successfully supported numerous companies under serious regulatory scrutiny.
RamsayPharma offer en-to-end support for your compliance and quality improvement projects. We can support you from day 1 to the end of your project. You can rely on us to help you every step of the way.