Compliant submissions, validated by design.
PharmX assembles, validates, reviews and dispatches electronic Common Technical Document (eCTD) submissions to health authorities — built around 21 CFR Part 11 and EU Annex 11 from day one.
Overview
Live operational snapshot
Lower platform cost
60%
Faster assembly
75%
Right-first-time submissions
95%
Trend
Health score
Everything PharmX brings together
Purpose-built modules that share one data model — so work captured once flows everywhere.
Publish
Generate eCTD backbones with MD5 checksums and lifecycle operations.
Validate
DTD, checksum, link and business-rule checking with severity grading.
Manage
Application and sequence lifecycle tracking with full audit trail.
Review
CTD-tree viewer with current and cumulative view reconstruction.
Dispatch
Package assembly for FDA ESG and EU CESP with acknowledgments.
Document Management
Versioning, check-in/out, e-signatures and metadata tagging.
Audit & Compliance
Immutable, attributable 21 CFR Part 11 audit trail and ALCOA+.
Regional Profiles
Pluggable US/EU/JP regions and eCTD standard versions.
The problems PharmX solves
The costly, everyday friction of running on disconnected tools.
What PharmX changes for regulatory teams
Making compliance a first-class design concern — not an afterthought — speeds every submission.
Run on a laptop, scale to cloud
Backbones auto-generated
Errors caught before they ship
Compliant by design
See PharmX build a compliant sequence
Watch a submission go from documents to a validated, dispatch-ready eCTD sequence — with the audit trail forming as you go.
- Publishing Module 1 + Modules 2–5 backbones with checksums
- Live validation: DTD, checksums, links and lifecycle rules
- Current vs. cumulative view reconstruction across sequences
- Dispatch packaging for FDA ESG / EU CESP gateways
Publish
Drill-down detail
Lower platform cost
60%
Faster assembly
75%
Right-first-time submissions
95%
Trend
Health score
Questions, answered
The things teams ask most before adopting PharmX.
eCTD v3.2.2 today with eCTD 4.0 / HL7 RPS planned, targeting FDA, EMA, Health Canada, PMDA, China NMPA and more.
Latest thinking on Pharma Regulatory & eCTD
eCTD lifecycle: reconstructing 'current state' across decades of sequences
Why dossier lifecycle tracking is the hardest — and most important — part of regulatory operations.
Read moreValidation by design: catching submission errors before they ship
How automated DTD, checksum and lifecycle checks prevent costly health-authority rejections.
Read moreBreaking free from six-figure regulatory publishing licenses
A look at how a config-driven platform delivers compliance without the vendor lock-in.
Read moreReady to Transform Your Organization?
Book a personalized consultation with our experts and see your measurable outcomes.