PharmaActdDossiers staff has extensive 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.
PharmaActdDossiers 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 (ISO14971)
- Regulatory submissions (IND, NDA, DCGI Files, COPP Data & Fixed dose combination etc.)