We listen carefully to you to understand your concerns and analyse the situation to highlight gaps which pose compliance risks in your chosen market. Our experts do this by undertaking thorough and informed due diligence of your project, performing a compliance check against regulations to pick up areas for improvement.
Once we analyse and identify the risks, we provide you with a diagnostic assessment and the best strategy to help get your project back on track, while reducing your risks and enhancing chances of success.
We will partner with you to implement the proposed remediation strategy based on our diagnostic assessment, support with remediation/process improvement activities and project manage the execution to ensure your project advances to completion, or approval, in a time efficient and compliant manner. We focus on compliance, speed and quality.
During evaluation of a complex submission, a European client found themselves at the risk of rejection, with the authority recommending withdrawal. This client approached Global Pharma Solutions for assistance and a rapid turnaround of this critical submission. We implemented our AAA Compliance Rescue package to help this client:
Our experts thoroughly reviewed the submission and agency evaluation reports to highlight critical risks leading to the withdrawal recommendation.
Once the risks were highlighted, Global Pharma Solutions provided immediate assessment and a remediation action plan, including engaging the authority with a face-to-face meeting to negotiate the path forward.
Global Pharma Solutions partnered with the client on strategy development and led the authority meeting, persuading them to accept current clinical data based on robust scientific justifications. Global Pharma Solutions further negotiated more time to conduct further supportive studies thereby overcoming compliance gaps, reducing the risk of rejection and enhancing chances of approval.