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Φ Complete database for dossier requirements
Φ Quick dossier compilation and review
Φ Draft pre-formulation, BMR, MFR, process validation, method validation, dissolution and stability studies documents
Φ Clinical and non-clinical overviews
Φ Justification for fixed dose combination
Φ Prepare Summary of product (SmPC) and Pack Information Leaflet (PIL)
Φ Prepare label and carton contents
Φ Reply to MOH queries
Φ Product registration assistance
Φ Product development assistance
Φ Global Patent Information
Φ Literature for patented product
Φ Non-infringing process

Dossier Format: As per country specific regulatory guideline / Asean CTD / EuCTD

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