KnowledgeNET - Regulatory Management Suite

Product Description

eCTD Publishing and  life cycle management :
KnowledgeNET, Publishing solution which create, compile, manage & publish your IND, NDA, ANDA, DMF, ASMF and CEP submissions effortlessly,

KnowledgeNET is fully compliant with ectd module 1 specifications EU, US FDA, GCC, South Africa (ZA-MCC) Health Canada (HC), Swissmedic, Thailand (Thai-FDA),  AU TGA  Jordan and similar regulatory authorities

Regulatory information management Systems (RIMS)

RIMS
is a centralized, platform that help manage global regulatory information across companies’ entire portfolio of products.
RIMS Benefits:
 
- Product submission processes and data management,
- Eliminating risk of non-compliance
- Detailed submission planning for each country specific regulations with improved 
- submission effectiveness
- Effectively manage post submission query/s raised by regulatory authorities,
- Eliminating delays because of queries and their responses
- Organize and track regulatory events (registration date, expiry date)
- Increase speed and quality of regulatory submissions
- Track status of commitments and correspondence to keep products on the market
- Electronic notifications to alert users of critical information updates
- Eliminate spreadsheets, tedious and error-prone manual data entry and linking
- Reduce all round operational costs by eliminating redundant systems
- Get easy access to all regulatory relevant product data

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
IT/Software solution provider
Pharmaceutical company
Primary activities
Regulatory Affairs
Technology
Specifications
  • Model
    eCTD, CTD, NeeS, ACTD, RIMS
  • Supplied from
    India

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
IT/Software solution provider
Pharmaceutical company
Primary activities
Regulatory Affairs
Technology

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