CS Exim Solutions is a global leader in regulatory consulting and dossier solution for export registration. We write and review dossiers as per guideline.
CTD
Module-1 (Regional & Administrative Information)
Module-2 (Quality Overall Summary)
Module-3 (Quality)
Module-4 (Nonclinical Study Reports- Safety)
Module-5 (Clinical Study Reports- Efficacy)
ACTD
Part I (Administrative Data)
Part II (Quality Summary)
Part III (Non Clinical Overview Summary)
Part IV (Clinical Overview Summary)
eCTD
Electronic version of CTD dossier accessed through the XML backbone.
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