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eSubmission Services
Preparing drug applications, amendments, annual reports, PADER submissions etc in eCTD format using industries leading eCTD preparation software
Validate the submissions using industries best validator which is used by FDA like agencies across the globe including EMEA
Note:
Our Parent organization is professional partners and official resellers of EXTEDO’s eCTDmanager for eCTD Preparation for USA and Asia. eCTDmanager is being used by agencies such as FDA in 35 countries across the globe including EMEA for reviewing and validating the submissions. Provide first level support for eCTDmanager software in NA and ASIA markets
SPL Preparation for Establishment Registrations, Labeler Code Requests, Drug Listings, GDUFA Self ID Submissions etc.
DUNS and establishment registration, self identification for all sites for drugs