Gap analysis

A Gap Analysis shows how your product aligns with regulations and the criteria for dossier submission.

Understanding your product's positioning within the regulatory landscape is critical for successful market entry. Our Gap Analysis service provides a comprehensive review, offering a clear perspective on how your product aligns with current regulations and the essential criteria for dossier submission. This analysis not only streamlines project planning by identifying necessary tests and creating efficient timelines but also prevents delays resulting from non-compliance or missing data.

Conducting a gap analysis at the project's inception is highly beneficial, setting a solid foundation for regulatory compliance. However, it is equally valuable at later stages as a verification tool, ensuring that all required tests have been conducted and meet the stipulated standards.

Our gap analysis services:


  • Identifying applicable regulations and guidance documents for your product.
  • Outlining the specific requirements and timeline needed to meet regulatory standards.
  • Evaluating different market access strategies concerning regulatory demands and project scheduling.
  • Reviewing your study plans and existing data for adherence to regulatory expectations.
  • Offering customised analyses to address your unique project needs.


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