Regulatory Submission Publishing

RegOrbit is your strategic partner to meet your goals in Regulatory Submission Publishing (eSubmission) activities and we provide flexible service and support to meet your company needs. Our qualified expertise team has an extensive experience in Regulatory Submission Publishing which includes Submission Management, Document Level Publishing and Submission Level Publishing.

Submission Management

  • Planning, managing, tracking, and ensuring on-time production and delivery of submissions across globe
  • Provide advice to optimize Efficiency and Quality
  • Submission Formats and Publishing Specification updates
  • Advise on technical and associated strategic submission elements such as Lifecycle implications, eCTD validation and ensuring a well-formed eCTD
  • Advising on new submission formats, the structure and ensuring a well-formed eCTD
  • eCTD Implementation in new countries accepting eCTD

Submission Level Publishing

  • eCTD/NeeS Compilation & QC Review
  • Lifecycle management and best practises for all eCTD submission types
  • eCTD/NeeS Technical Validation
  • Submission data transfer to Health Authorities via Agency Gateway\Portal
  • CD/DVD burning and dispatch tracking
  • Importing and Cloning of Existing eCTD/NeeS Applications – reuse
  • Converting NeeS/Paper to eCTD

Document Level Publishing

  • Formatting of Word documents for technical integrity & ease of future revisions
  • Document-level PDF publishing for use in global submissions
  • Hyperlinking and bookmarking per agency requirements
  • Report publishing including CSRs, RMPs, Safety Reports, IMPDs
  • Creating templates for authors for use internally within your company, saving time and ensuring consistency

RegOrbit Supports following regions/countries eCTD dossier preparation

  • USA
  • Europe (Centralized, MRP, DCP, National)
  • EDQM – Certificate of Suitability (CEP)
  • Switzerland
  • GCC (Saudi Arabia, Bahrain, UAE, Qatar, Oman, Kuwait)
  • Australia
  • Thailand
  • China
  • Japan
  • Canada
  • Jordan
  • South Africa
  • Eurasian Economic Union (EAEU)