Clinical Development

At the clinical development stage of the medicine or product lifecycle, a Quality Management System (QMS) is required to:

• Ensure Good Documentation Practices are adhered to
• Support product quality monitoring throughout development to establish control strategies for manufacturing
• Monitor any outsourced activities of product development to ensure the quality of the data gathered and provide more structure to the development studies
• Manage outsourced clinical trial studies and small-scale clinical manufacturing of investigational medicinal product
• Identify any improvements on the robustness of the scaled-up manufacturing process
• Support in obtaining a manufacturing licence for investigational medicinal product.

We can help by developing a QMS which addresses all the above requirements, including performing risk assessments, product quality reviews, corrective and preventative actions and change control management.

We can also help with specific licences such as the Medicines Healthcare Product Regulatory Authority MIA (IMP) Licence.