Confidence Beyond Compliance

The success of regulatory approvals is highly dependent on the quality of the data submitted. Completing a comprehensive review of regulatory requirements, designing studies to ensure they provide the necessary supportive evidence and assessing all the relevant existing scientific data, are the essential stages required in order to develop a solid route to market. Assessing scientific data can help companies answer important questions relating to particular components of a product development programme. The assessment may focus on quality (CMC), non-clinical or clinical information. Regulatory authority scientific advice provides an invaluable opportunity to ask prospective questions before the studies have taken place to ascertain whether the design of the study meets local or regional expectations and whether it is likely to generate data suitable for the application. The significance of this opportunity should not be underestimated. Identifying and resolving any weaknesses and omissions in the data at an early stage in the project, will allow sufficient time to resolve the issues and help gain regulatory authority endorsement whilst at the same time prevent any resultant delay to the approval process.

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