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Dossier - Writing & Review


MYdossier is a global leader in regulatory consulting and dossier solution for export 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
- Global Patent Information and Literature for patented product
- PSUR (Periodic Safety Update Reports)

Technical Documentation (writeing and review):-
- Summaries - Quality, Clinical & Non-clinical
- Drug master file (S Part of Dossier)
- Clinical & 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)

We are capable to prepare dossier for more than 90 countries.

We are also selling dossier for ROW market.