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.

A gap analysis and research services can include:


  • identification of relevant regulations and guidance documents
  • outlining the requirements and timeline for your product
  • consideration of various market access options as regards the requirements and timing
  • review of study plans and data for regulatory compliance
  • analyses that can be tailored to fit your specific needs


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