Gap analysis and regulatory compliance review
Gap analysis will give you an overview 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 timeline helps in planning the project without unnecessary delays due to missing or incompliant data.
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 check point to make sure that all relevant tests have been conducted and comply to the requirements.
Our services 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
For more information, contact us
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