Global Pharma Solutions is partnering with companies globally and is actively involved in COVID-19 market authorisation support.

Compliance rescue AAA service

Have you ever found yourself in a situation where you’re unsure of how to begin or progress your project? Have you ever been worried about non-compliance with regulatory, clinical or ethics committee requirements?

Whether it be a clinical trial, new medicine registration, compliance project or an upcoming authority inspection, we offer a compliance rescue package to help you ensure you meet compliance and get your medicine to patients faster. Our compliance rescue focuses on 3 main principles: Analyse, Assess, Approve.

ANALYSE

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.

ASSESS

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.

APPROVE

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.

CASE STUDY

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:

ANALYSE

Our experts thoroughly reviewed the submission and agency evaluation reports to highlight critical risks leading to the withdrawal recommendation.

ASSESS

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.

APPROVE

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.

If you’d like to find out more about our compliance rescue contact us for an initial discussion.

Deprecated: printf(): Passing null to parameter #1 ($format) of type string is deprecated in /home/globalpharmasolu/public_html/wp-content/themes/gps_child/blocks/footer.php on line 8

Deprecated: printf(): Passing null to parameter #1 ($format) of type string is deprecated in /home/globalpharmasolu/public_html/wp-content/themes/gps_child/blocks/footer.php on line 9

Deprecated: printf(): Passing null to parameter #1 ($format) of type string is deprecated in /home/globalpharmasolu/public_html/wp-content/themes/gps_child/blocks/footer.php on line 10