Drug Regulatory Writing-Dossier-ACTD-CTD-DMF

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CORE REGULATORY SERVICES

CTD and eCTD submissions on all types of drug products
US and Canadian Drug Master file(DMF) for API, Excipients, Packaging Materials
Certificate of Suitability as per EP (CEP)
Summary of Product Characteristics (SmPC)
Periodic Safety Updates (PSUR)
New Drug Application(NDA) , Investigational New Drug Application(IND)Abbreviated New Drug application (NDA)