Regulatory - KnowledgeNET - RIMS | eCTD | eCSV

  • Regulatory - KnowledgeNET - RIMS | eCTD | eCSV 1
  • Regulatory - KnowledgeNET - RIMS | eCTD | eCSV 2
  • Regulatory - KnowledgeNET - RIMS | eCTD | eCSV 3
Product Description

KnowledgeNET is a global dossier publishing & management software empowering pharma industries to achieve regulatory compliance efficiently.

  • eCTD Publishing: DMF | ASMF | CEP | ANDA | IND | BLA | PADER | PSUR | 510(K)
  • CTD/ ACTD and Regional Submissions
  • Query and Life Cycle Management
  • SPL, ER, NDC, GDUFA, Drug Listing
  • eCTD Viewer
RIMS is a centralized, platform that helps manage global regulatory information across companies’ entire portfolio of products.
  • Submission, Planning & Tracking
  • License Management
  • Registration/ Approval/ Renewal Management
  • Variation Management
  • Artwork management
eCSV is a globally compliant, automated CSV solution.
  • Automation of CSV for GAMP 5 Category
  • Document Authorization
  • Automated screenshot capture for validation of test scripts and summary report

Read more Show less

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
Consultancy
IT/Software solution provider
Primary activities
Clinical Research
Contract Research Organisation
Other
Regulatory Affairs
Technology
View company profile
Categories
more categories Show less
Specifications
  • Details
    80+ Customers | 5000+ Dossiers Submitted | 1000+ Users
  • Model
    Cloud Ready, IDMP and Globally Compliant, Pre-Validated, Go Live in 2 weeks
  • Supplied from
    India
More specifications Fewer specifications
Sales Markets
Show more Show less

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
Consultancy
IT/Software solution provider
Primary activities
Clinical Research
Contract Research Organisation
Other
Regulatory Affairs
Technology
View company profile

More Products from Sarjen Systems Private Limited (4)

  • Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite

    Product Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite

    AI-enabled, cloud-ready,360 pharmacovigilance solution for safety database management. An end-to-end globally compliant safety software for Drugs, Devices, Vaccines and Combinational products from case intake to submissions and reporting. • Case Intake • Case Processing • Case Submission • Risk Manage...
  • Quality - QEdge - Enterprise Quality Management Suite

    Product Quality - QEdge - Enterprise Quality Management Suite

    Sarjen Systems’ QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:
    • Process Control • Document Control & Issuance • Training Management System • Ve...
  • Manufacturing - ProcessXE - Smart Manufacturing & Automations Suite

    Product Manufacturing - ProcessXE - Smart Manufacturing & Automations Suite

    Sarjen Systems' ProcessXE is a SMART manufacturing solution tailored for the pharmaceutical industry. This solution provides the following offerings
    • Weighing & Dispensing Management • Electronic Batch Manufacturing Record​​ • Electronic Batch Packaging Record​ • Equipment Qualification...
  • Business - FForce – SFA | SFE | CRM | DMS | Sales

    Product Business - FForce – SFA | SFE | CRM | DMS | Sales

    FForce helps sales teams manage leads, automate tasks, and track performance to close deals faster and grow revenue.

    Modules:
    • Sales Force Automation: Automates lead management, CRM tasks, and sales tracking.

    • Digital Engagement Platform: Connects with customers across chan...

Sarjen Systems Private Limited resources (1)