Business and GxP compliant solutions, services by SarjenBusiness and GxP compliant solutions, services by SarjenBusiness and GxP compliant solutions, services by Sarjen

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

Fasten your regulatory approvals and scale your business

Impact

1 +

Country structures

1 +

Semi-regulated markets submissions

1 +

Dossiers

1 +

Non-regulated markets submissions

1 +

SPLs

Features

Dossier Management

Region-specific Dossier Management

Seamless Automations

Product-based Dossier Lifecycle

Automated Submission Workflow

Automated submission workflow

FDA and EU-compliant Workflows

Regulatory compliance support

Real-time Document Tracking

Real-time document tracking

version-control

Version control

Review & Approval

Easy Dossier review & approval

Boosted ROI and Accuracy

Boosted ROI and accuracy

Other domains served by Sarjen

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