RegOrbit experts are directly involved and contributed review of the EU ISO IDMP Implementation guidelines (IG), ICH eCTD v4.0 Implementation Guide, FDA, EMA, Swissmedic, Health Canada and PMDA (Japan) regional eCTD v4.0 implementation packages and represents various industry forums and Our experts are here to support your organization to prepare and ready for the move to IDMP & eCTD v4.0


  • SPOR/IDMP readiness, gap analysis and future state recommendation
  • Provide comprehensive processes for SPOR/IDMP data management covering data gathering, data mapping, data curation, data enrichment, data validation, data maintenance and governance
  • Establish substance and product data model, integrate with EMA SPOR database to enable IDMP submissions

eCTD v4.0

  • The next major evolution in electronic submissions will be the transition from eCTD version 3.2.2 to eCTD version 4.0
  • Offer insight about eCTD v4.0 including new features such as two-way communication, document reuse, group documents etc
  • Support and analyze challenges associated with the transition from eCTD v3.2.2. to v4.0 – both from a technical and regulatory perspective
  • Develop high level transition plans from eCTD v3.2.2 to next generation eCTD v4.0 with standardized controlled vocabularies to enable interoperability in your eCTD v4.0 submissions