Gap analysis and regulatory compliance review

A gap analysis will give you an overview of where your product stands in the regulatory framework and what requirements a high-quality dossier must fulfil when submitted to the authorities for safety evaluation. Having a list of testing requirements and a timeline helps in planning the project without unnecessary delays due to missing or incompliant data.

A gap analysis is most useful when made at an early phase of the project. If you are already at an advanced stage, the analysis can be used as a checkpoint to make sure that all relevant tests have been conducted and comply with the requirements.