Pharma ACTD Dossiers staff has extensive Literature Search & Review, medical writing experience including Pre-Clinical and Clinical Study Reports, INDs, Fast Track Applications, New Drug Molecules and clinical summaries for Safety and Efficacy, ACTD, CTD and eCTD submission format.

Pharma E-CTD/ ACTD Dossiers service offering the following:

Preparation and submission of Regulatory documentation including:

• PSUR (Periodic Safety Update Reports)
• PV or PhV (Pharmacovigilance Study Report)
• BA/BE ( Bioavailability /Bioequivalence) Studies Reports.
• CSR (Clinical Study Reports)
• Preclinical reports
• QMS (Quality Managements System)
• Expert Reports
• Regulatory/Quality GAP Analysis.
• Package Inserts / summary of product characteristic (SmPC)
• Labeling Protocols SOPs
• Risk Management Plan