Leiwen Pharmaura 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)
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.