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Smarter dossier management for faster approvals
Our global dossier publishing platform simplifies dossier management and submission. By automating workflows for regions and products, it ensures a consistent and efficient process, reducing complexity and improving accuracy.
Using our global dossier management and publishing platform helps standardise and streamline your regulatory submission process. With automated workflows tailored to specific regions, products, and regulatory authorities, it accelerates dossier creation, validation, and submission. This results in fewer compliance issues, reduced manual errors, and faster regulatory approvals. Our solution increases operational efficiency, ensures data consistency, and supports audit-ready documentation—saving time, improving accuracy, and keeping your submissions compliant so you can focus on scaling your business.
What makes eCTD/CTD/NeeS Publishing solution by Sarjen stand out?
eCTD publishing & submission (DMF | ASMF | CEP | ANDA | IND | NDA | BLA | PADER | PSUR | 510(k)
Regulatory information management system (RIMS)
Query & life cycle management
CTD/ACTS and regional publishing
SPL, ER, NDC, GDUFA, drug listing
eCTD viewer

Impact
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Country structures
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Semi-regulated markets submissions
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Dossiers
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Non-regulated markets submissions
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SPLs
Features

Region-specific Dossier Management

Product-based Dossier Lifecycle

Automated submission workflow

Regulatory compliance support

Real-time document tracking

Version control

Easy Dossier review & approval

Boosted ROI and accuracy
Other domains served by Sarjen
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