Through the extensive regulatory intelligence, we ensure fully compliant content, using experience, analysis of precedents and new regulatory tools to create smart dossiers.
We know this proven approach contributes to faster approvals, and reduces the number of changes with regulatory impact, throughout your product’s life cycle.
Dossier GAP analysis entails a critical and empirical examination of the supporting materials for your pharmaceutical products. Registration processes are made simpler when medicinal product dossiers are properly analyzed and evaluated and meet local standards.
In accordance with Health Authority standards, we offer the following services in the evaluation of the pharmaceutical product dossier:
- Verification of missing points on the entire dossier or by individual modules
- Administrative information (Module 1)
- Summary, both clinical and non-clinical (Modules 2.4-2.7)
- Data on Non-Clinical and Clinical Safety and Efficacy (Modules 4 and 5)
- Report on GAP analyses with recommendations for dossier amendments is provided.
Our internal and external specialists will review the dossier to identify any potential weak points, potential informational gaps, and appropriate updates for any missing or incorrect material.
We can review and provide advice on additional requirements in accordance with current laws and regulations to support client companies licensing during product development or post-approval, updating an older licence, or converting from NDA to MAA