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

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Sarjen Systems Private Limited

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

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

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    PvEdge PvXtract stands as a next-generation AI-powered solution designed to streamline and accelerate your literature screening process. Built with deep domain intelligence, PvXtract automates manual review tasks, ensuring faster, more accurate identification of safety information from a wide range of global literature sources.

    With advanced Natural Language Processing (NLP) and Machine Learning capabilities, PvXtract intelligently extracts relevant case information, classifies data, and filters out non-relevant articles—saving valuable time for safety professionals.

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    Brochure Sarjen Profile

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