Vocabulary design
Design your customized CMC vocabulary extending IDMP-O, Allotrope, and ISA88 — rooted in gist-Pharma.
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.
What Is Regulatory Intelligence
Every drug starts from scratch. It doesn’t have to.
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 platform.
From a raw source to a governed knowledge graph — with answers that trace back to the row they came from.
Connect any source.CSV, API, Postgres, Snowflake, Salesforce — Fluree ingests it as-is. No schema migration. No pipelines to maintain.
The graph builds itself.Entities resolve, duplicates merge, and relationships infer in place — no modeling marathon, no manual ontology.
Answers, with receipts.Ask in plain language. Every answer traces back to the exact row it came from — for humans, agents, and apps alike.
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.
Capability | Traditional CMC + RIM workflows | Fluree DMKA + gist-Pharma |
|---|---|---|
eCTD Module 3 preparation | Manual compilation, 9–12 months | Auto-populated from the knowledge asset — 33% faster |
Terminology across labs | Inconsistent per-site conventions | Universal CMC vocabulary mapped to gist-Pharma |
Cross-lab data sharing | Siloed, duplicated testing | One governed vocabulary — shared reuse across labs |
Cross-modality reuse | Each modality starts from scratch | Knowledge asset extends across modalities |
Regulatory change mgmt | Manual monitoring + spreadsheets | AI surfaces every affected submission automatically |
Audit defense | Manual research, weeks to answer | Query — source, transformation, approval in seconds |
Audit trail | Partial, per-system logs | Immutable, cryptographic, source-to-submission |
Ontology alignment | Proprietary or per-project models | gist-Pharma extending IDMP-O, Allotrope, ISA88 |
Global site integration | Requires centralized data | Virtual connection across firewalled global sites |
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
Recognized by Gartner
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.