Dossier GAP analysis involves a critical and scientific analysis of your medicinal product documentation. Properly analyzed and assessed medicinal product dossiers conform to local requirements in the Eurasian Economic Union region lead to easier registration procedures.
We provide the following services in the medicinal product dossier evaluation according to EAEU regulations:
- Verification of missing points on full dossier or by separate Modules:
- Administrative data (Module 1)
- Non-Clinical and Clinical Summaries, Overviews (Modules 2.4-2.7)
- Non-Clinical and Clinical Safety and Efficacy Data (Modules 4 and 5)
- Provision of GAP analyses report with recommendations on the dossier amendment.
The dossier will be examined by our internal and external experts to highlight probable weak parts and possible gaps in information extensiveness and relevant and suitable solutions to update the missing on improper information.
For any inquiry regarding our services, please contact Biomapas Business Development team.