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OUR SERVICES
REGULATORY • CDSCO Application Assistance
SERVICES • CTD Dossier/ DMF Compilation
• Analytical Method Validation (AMV)
• Comparative Dissolution Profile (CDP)
• Bio-Waiver Report Compilation
• Experts Review of Clinical for CTD Dossier
• Experts Review of Preclinical for CTD Dossier
PHARMACOVIGILANCE • End to end processing & submission of Independent Case Study
Report (ICSR)
SERVICES
• Aggregate Report Writing & Review
(PSUR/PBRER/PADER/DSUR)
• SOP of Pharmacovigilance