eCTD CTD - KnowledgeNET

eCTD CTD - KnowledgeNET
Product Description

Dossier life cycle management and publishing solution which create, compile, manage & publish your IND, NDA, ANDA, DMF, ASMF and CEP submissions effortlessly,
Knowledgenet is a complete eCTD dossier publishing & submission solution and is fully compliant with ectd module 1 specifications EU v3.0.3, US FDA (v2.01 and v2.3), GCC v1.2 and v1.5, South Africa (ZA-MCC) v2.1, Canada v2.2, Swissmedic (CH) v1.4, Thailand (Thai-FDA) v1.0, AU v3.1, Jordan v1.0.2 and similar regulatory authorities and NeeS specifications EU v4.0, GCC v1.2 and v1.5, AU v2.0

Read more Show less

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 2
    Certificates
  • 250 - 499
    Employees
Company types
Consultancy
View company profile
Categories
more categories Show less
Specifications
  • Supplied from
    India
More specifications Fewer specifications
Sales Markets
Show more Show less

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 2
    Certificates
  • 250 - 499
    Employees
Company types
Consultancy
View company profile

More Products from Sarjen Systems Private Limited (4)

  • CTM, Clinical Research, BA/BE Studies, BizNET

    Product CTM, Clinical Research, BA/BE Studies, BizNET

    BizNET-CTM, an end-to-end platform for clinical trials; right from Early phase, Late phase, Oncology to Registry to Post approval trials.

    Suite of solutions for Clinical Research:

    > eCRF, EDC and Clinical Data Management
    > IWRS and Pharmacy Management
    > Medic...
  • eBMR. BCR, MES, ProcessXE

    Product eBMR. BCR, MES, ProcessXE

    Process XE, smart manufacturing automattion solution; helps digitise entire manufacturing process, easily integrable with enterprise business systems improving operational visibility and compliance
    across production value chain.
    Suite of solutions for Process automation:

    > El...
  • Quality management, Document management, Trianing management, eQMS, QMS, QEdge

    Product Quality management, Document management, Trianing management, eQMS, QMS, QEdge

    QEdge helps organisations manage all round Quality on a single platform across multiple sites.
    A fully compliant, digitised, AI enabled solution for effortless AUDIT READINESS, avoid data integrity issues.

    Some of successfully configured processes:


    > Quality Processe...
  • Pharmacovigilance - PvEdge

    Product Pharmacovigilance - PvEdge

    PvEdge, a safety reporting tool provides comprehensive analyses of adverse events arising from the use of pharmaceutical products (Drug, Medical Device or Therapy, Vaccine). It is an advanced Pharmacovigilance solution that helps combat the complexity of the safety data and comprehensively caters to all risk ...