Regulatory Technology & Standards

Regulatory authorities GxP guidelines are constantly evolving and life science industries are expected to align technology in a secured, managed and controlled way. RegOrbit help to ensure your Regulatory technology & Standards aligns to industry needs and regulatory requirements.

Technology & Standards

  • We support for authoring a user requirements specification (URS) and Functional requirement specification (FRS) to be used for selection of suitable Regualtory IT solution and provide project management service for implementing of selected solution, which includes
    • Electronic Document Manamgnet System (EDMS)
    • Regualtory Information Management System (RIMS)
    • Submission Publishing software’s (eCTD, NeeS, Paper)
    • Submission Viewer
    • Submission Validators
    • Regulatory Data visualizing & Reporting tools
    • Regulatory Authoring Template
    • Submission Planning and Tracking
    • Labelling Management software’s (SPL & SPM)
  • Support to negotiate and manage contracts / SLAs with software and data center vendors and develop Regulatory IT strategies
  • Provide expertise in system design, process development, authoring of validation documentation including qualification documentation, training and user documentation, test scripts (OQ and UAT)
  • Help regulatory system integrations and/or upgrades and data migration activities we act as a link between IT and business teams and translate your business requirements to IT language
  • Our expert supports your users and maintain operation and we offer fflexible service for your business requirements