Vocabulary design
Design your customized CMC vocabulary extending IDMP-O, Allotrope, and ISA88 — rooted in gist-Pharma.
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Pharma · Regulatory intelligence
Cut time to regulatory approval by 33%.
Your CMC data is scattered across LIMS, ERP, MERS, and dozens of lab systems — each with different formats, terminology, and no shared vocabulary. Fluree unifies it into a reusable Drug Manufacturing Knowledge Asset that accelerates eCTD preparation from 9 months to 6 — and makes every subsequent submission faster.
Definition
What is regulatory intelligence?
After Stage III clinical trials, the real bottleneck begins. Regulatory compliance teams must integrate thousands of pages of CMC evidence — test results, stability data, batch records, analytical methods, process controls — into one coherent submission. Fragmentation across LIMS, ERP, MERS, and lab systems means every drug starts the integration process over.
Fluree and Semantic Arts combine ontology expertise with knowledge graph technology to create a Drug Manufacturing Knowledge Asset: a unified, semantically structured view of compounds, tests, equipment, processes, batches, and recipes — mapped to the gist-Pharma ontology regulators understand.
Build it once. Reuse it for every drug. Every subsequent submission is faster, more consistent, and more defensible.
Three steps.
One Drug Manufacturing Knowledge Asset.
From CMC silos to submission-ready knowledge — with regulatory lineage for every data point.
Connect CMC systems.LIMS, ERP, MERS, stability feeds — Fluree reads them in place. No migration, no duplication.
Classify against gist-Pharma.AI maps your terms to the regulatory ontology automatically. 'Assay' and 'analytical test' resolve to one concept.
Assemble eCTD in weeks.Module 3 populates from connected data. Cross-references resolve automatically; every data point traces back to source.
What Fluree Unlocks For Regulatory TeamsSix capabilities no LIMS, ERP, or RIM platform
Six capabilities no LIMS, ERP, or RIM platform
gives you on its own.
Module 3 and 2.3 populate from connected data, not manual compilation
Your Drug Manufacturing Knowledge Asset pre-integrates CMC data from every source. Regulatory teams query the graph instead of compiling evidence by hand — Module 3 quality sections populate from verified, cross-referenced data, and the Quality Overall Summary drafts itself.
- Draft preparation: 9 months → 6 months
- Each drug in the same modality is faster than the last
- Every data point traces back to source
Traditional submission prep vs.
Fluree Drug Manufacturing Knowledge Asset.
A direct comparison of manual CMC workflows against the knowledge-asset approach — across every dimension that affects submission timelines.
In Production
Live at a Tier 1 Global Pharmaceutical Organization.
We use Fluree to streamline data classification and integration across CMC workflows at a Tier 1 Global Pharmaceutical Organization. We’ve seen faster time-to-market as the result of enabling data-driven collaboration in CMC workflows and eCTD document prep, enabling us to capture upwards of $150M in opportunity cost per month saved.
The regulatory intelligence playbook.
Whitepapers, practitioner guides, and one-pagers covering every dimension of the eCTD knowledge-asset approach.
Partner whitepaper
Semantic data exchange for life sciences.
Download whitepaperPractitioner guide
Automating Regulatory Compliance With Knowledge Graphs
How a governed knowledge graph turns submission prep from a quarterly project into a continuous capability.
Read the articleRegulatory
How Semantic Data Accelerates Regulatory Compliance in Pharma
Why linked-data and governed vocabularies collapse the time from trial close to submission-ready data.
Read the articleOne-pager
Download one-pagerPharma knowledge graphs — drug cost efficiency.
How life-sciences teams connect trial, compound, and manufacturing data to surface cost-efficiency opportunities across pharma operations.
Get Started
90-day pilot — proof of concept for one modality.
Fluree and Semantic Arts deliver a working Drug Manufacturing Knowledge Asset in 90 days by integrating LIMS and ERP data against gist-Pharma — validated on eCTD competency questions for your chosen modality.
Data integration & classification
Connect LIMS and ERP systems. Auto-classify data elements against the universal vocabulary with AI.
Knowledge asset & validation
Deliver a working Drug Manufacturing Knowledge Asset. Validate against eCTD competency questions and generate queryable evidence.
Outcome
A working proof of concept that demonstrates a 33% timeline reduction potential for your specific modality and data landscape — against real eCTD competency questions.
FAQ
A unified, semantically structured knowledge graph that connects all CMC data — compounds, tests, equipment, processes, batches, recipes — mapped to an ontology framework that regulatory agencies understand. Build it once for a modality, reuse it for every drug in that modality.
gist-Pharma is an ontology from Semantic Arts specifically designed for pharmaceutical manufacturing. It provides the standardized semantic framework for eCTD competency questions — the same concepts and relationships regulatory agencies use to evaluate submissions.
No. Fluree connects to your existing systems and creates a unified knowledge graph on top. LIMS, ERP, MERS, and lab systems stay in place. Data doesn’t move — Fluree integrates it semantically.
Fluree creates a universal CMC vocabulary that maps your site-specific terms to standardized concepts. 'Assay' in Lab A and 'analytical test' in Lab B resolve to the same concept; AI auto-classifies data against this vocabulary at source.
The knowledge graph approach is inherently eCTD v4.0-ready. Structured, semantic data maps naturally to the granular, FHIR-compatible data model that v4.0 requires — organizations building knowledge assets now transition to v4.0 seamlessly.
90 days. Delivers a proof of concept for one modality (Small Molecule or Large Molecule) by integrating LIMS and ERP data, demonstrating queryable evidence generation and timeline reduction against eCTD competency questions.
Yes. Fluree’s architecture supports data integration across heterogeneous systems on firewalled networks globally. Analysts can query and generate evidence without centralizing data in one location.
Every month of delayed market entry costs $150M+ in lost opportunity for a major drug. Reducing the submission timeline by three months represents hundreds of millions in accelerated revenue. The 90-day pilot validates this potential for your specific pipeline.
Recognized by Gartner
Gartner, “Cool Vendors in Data Management: GenAI Disrupts Traditional Technologies,” 30 May 2024. GARTNER and COOL VENDORS are registered trademarks of Gartner, Inc. and/or its affiliates and are used herein with permission. Gartner does not endorse any vendor, product or service depicted in its research publications.
Your CMC data doesn’t have to be the bottleneck.
Fluree’s Drug Manufacturing Knowledge Assets cut submission timelines by 33% — and make every subsequent drug faster.
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