Web-based & server-based software

Web-based & server-based software
Product Description

-Creating, managing, compiling, publishing, reviewing, validating, and archiving dossiers in fully compliant eCTD format, meeting the highest Regulatory (Regional and ICH) specifications. -Chemical Structure Drawing Tool Electronic Lab Notebook (ELN) 
-Laboratory Information Management System (LIMS) 
-Quality Management System (QMS) Document Management System (DMS) Learning
-Management System (LMS)Electronic Batch Manufacturing Records (eBMR)

Read more Show less

WORLDWIDE-COMPLIANCE

  • IN
  • 2023
    On CPHI since
  • 4
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Primary activities
Other
Regulatory Affairs
View company profile
Categories
more categories Show less
Specifications
  • Details
    As per 21 CFR Part 11 Guideline - Electronic Records: Electronic Signatures
  • Selling Points
    Quality Service
  • Supplied from
    India
More specifications Fewer specifications

WORLDWIDE-COMPLIANCE

  • IN
  • 2023
    On CPHI since
  • 4
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Primary activities
Other
Regulatory Affairs
View company profile

More Products from WORLDWIDE-COMPLIANCE (2)

  • Quality Compliance

    Product Quality Compliance

    Support for all departments: Operations, Engineering, Finance, Regulatory, Business Development, IT, Research & Development • Ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environme...
  • Regulatory affairs services

    Product Regulatory affairs services

     Regulatory affairs: Dossier compilation CTD,ACTD,Nees,e CTD- Format-DMF, CEP, ASMF, IND, NDA, ANDA, BLA, MAA,505(b)(2), Paper submission, old product dossier conversion for any Dosage Form and Application Regulatory Operation: Type. Global CTD Conversion/publishing-Document Level, Submission...