Major Features
- Applications for INDs, NDAs, ANDAs, DMFs, MAA, IRP, line extensions, and many more.
- CTD compilations of modules, overviews.
- License renewals and Variations Type I and Type II
- Orphan drug applications
- Summary of Product Characteristics, Patient Information Leaflet and labeling
- Prescribing information preparation and review
- Clinical trial applications
- Promotional material review and approval
- Variations and supplements
- Maintenance and regulatory life cycle management
- Submission Planning and Management (eCTD / NeeS / Paper)
- Resource Planning and Coordination
- Content Publishing and Tracking
- Submissions Assembly and Review
- Component Compliance Checking
- Submission Dispatch/ Uploading on ESG
