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Dossier Services
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⊕ Quick dossier compilation and review
⊕ Draft pre-formulation, BMR, MFR, process validation, method validation, dissolution and stability studies documents
⊕ Clinical and non-clinical overviews
⊕ Justification for fixed dose combination
⊕ Prepare Summary of product (SmPC) and Pack Information Leaflet (PIL)
⊕ Prepare label and carton contents
⊕ Reply to MOH queries
⊕ Product registration assistance
⊕ Product development assistance
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⊕ Literature for patented product
⊕ Non-infringing process
Dossier Format: As per country specific regulatory guideline / Asean CTD / CTD
