Skills and Experiences

Sage Submissions has extensive experience with standard industry software and systems, including:

  • Electronic Document Management Systems – Documentum, Livelink, MasterControl, QUMAS, SharePoint (base and compliance solutions running on SharePoint)

  • Publishing Systems – CSC eCTDXpress, Extedo eCTDmanager, Liquent CoreDossier and Insight Publisher, Lorenz docuBridge

  • Adobe Tools – Acrobat Professional, Compose, Photoshop, Captivate, CSC TRSToolbox (Standard and Pharma), Liquent SmartDesk, ProFocus PitStop Professional

  • Microsoft Products – Office (Word Templates, Excel Databases), Access, Visio, Project

  • FDA Electronic Submissions Gateway (ESG) - implementation and maintenance; US agent for submitting eCTD and SPL submissions via ESG on behalf of sponsor

We also have vast industry experience in submitting all formats of regulated information to global regulatory authorities, including:

  • Investigational Applications (IND, eIND, and CTA)

  • Marketing Applications (NDA, eNDA, MAA, and eCTD)

  • Promotional Materials

  • Labeling (SPL, PLR)