Test specifications
Assembled from approved tests, methods, and acceptance criteria.
One source of CMC content. Submission-ready for Module 3.
Test specifications, analytical procedures, and stability, managed as approved, reusable components. Consistent, traceable, and submission-ready for eCTD Module 3, with FHIR/XML-ready outputs for what's coming next.
Structured content reuse
100,000→5,000
legacy documentsreusable components
95% reduction at go-live
15 yrs in production
The shift
Similar specs, authored from scratch, again and again.
Aging systems need specialist support and can't reuse content, so near-identical test specifications get rebuilt across products and sites. The volume becomes unsustainable.
Component-based authoring breaks the cycle: write a test, method, or analytical procedure once, then assemble it into every specification that needs it.
What we structure
Product quality content, built to be reused and submitted.
Analytical procedures
Authored once, linked into every specification that uses them.
Stability
Structured stability content and summaries, consistent across studies.
FHIR & XML at scale
Generate compliant XML at the scale and complexity now required, and auto-convert unstructured content into structured data.
eCTD acceleration
Turn complex technical work into submission-ready content.
Structured, reusable CMC content compresses the manual effort between scientific source, authoring, and Module 3, so submissions come together faster and more consistently.
Structure CMC content
Turn technical sections, tables, and data-heavy narratives into managed components.
Reuse data & text
Cut repeated authoring across products, sites, changes, and recurring reports.
Improve traceability
Make technical content easier to review, verify, update, and defend.
Publish for submission
Publish human-readable and structured outputs directly, no separate publishing vendor, moving CMC closer to eCTD-ready.
Authoring efficiency
Reduce weeks of manual technical writing, formatting, and update work.
Quality & consistency
Improve consistency and traceability across technical content and reviews.
Future readiness
Prepare CMC operations for structured submissions and evolving expectations.
Customer story
CMC content management across four global manufacturing facilities.
Teams now create test specifications by assembling pre-approved, reusable components instead of authoring full documents from scratch.
A large German pharmaceutical
A long-running CMC content program spanning four global manufacturing facilities.
- 100,000 legacy documents consolidated to 5,000 reusable components
- Content authored once and reused, eliminating redundant authoring
- Reduced support personnel required to maintain the system
1,000+
users across 4 global facilities
95%
less data at go-live
15 yrs
in continuous production
See structured CMC content with your own data.
A focused walkthrough on your test specs, analytical procedures, and stability, and how they accelerate your eCTD timelines.