Dossier – Writing & Review
Sarims provides consulting and dossier solution for product registration. We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline).
Administrative Documentation (writing and review):
• Registration Application & Covering Letter
• Letter of Authorisation
• Legal & Administrative (GMP,CoPP, FSC etc) Documents
• Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert
• Label and carton contents
Technical Documentation (writing and review):
• Summaries – Quality & Non-clinical
• Drug master file (S Part of Dossier)
• Non-clinical Overview (Module 2)
• PDR, Process validation, AMV & Stability Studies
• Specification, Method of analysis & Certificate of Analysis of Raw materials & Packing Materials
• Specification, Method of analysis & Certificate of Analysis of Formulation product
• Module 4 (Non-clinical)
• Module 5 (Non-clinical)
Common Technical Document (CTD)
The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed as per the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
We prepare all modules of Common Technical Document:
Module 1. Administrative information and prescribing information
Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)
Module 3. Quality
Module 4. Nonclinical Study Reports (toxicology studies)
Module 5. Clinical Study Reports
