Your CRL just landed.
Now, cut your response time by half.
Extract every deficiency, map it to your data, and draft a source-cited response, all inside your existing Databricks Lakehouse.
Submission NDA 217045 Overview
Response deadline:
27 days remaining
TOTAL CRL ITEMS
Extracted by AI in 4 min
14
ITEMS RESOLVED
43% complete
6
IN PROGRESS
On track
5
TIME TO RESUBMIT
vs. 14 mo industry avg
5.2 mo
Response Timeline vs. Industry Benchmark
Projected completion by activity area
CRL Items by Category
Classified and linked to data assets automatically
Data Readiness
Other Submissions
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THE PROBLEM
Time is money when you receive a CRL.
📄
Deficiencies buried in PDFs
Regulatory affairs manually reads every deficiency and builds a tracker by hand.
Gap analysis alone takes 6 weeks.
Even with governed, unified data, most response processes remain highly manual.
📈
Reanalyses executed one at a time
Biostatisticians run sensitivity analyses sequentially; one finishes, then the next one starts.
That queue can add up to 3 months.
💰
Data scattered across disconnect systems
Pulling one integrated safety dataset across trials takes weeks on its own.
Disconnect systems can add 6 or more months.
BUSINESS RESULTS
Seven months faster.
That changes who gets to market first.
For a drug with a projected impact of $1B at peak-sales, every month between a CRL and resubmission costs roughly $83M in deferred revenue.
THE SOLUTION
The same response.
Five months instead of twelve.
One workflow, four stages, start to finish: your data is already unified in Databricks, this is the workflow layer that gets built on top of that.
AI reads the letter the moment it's uploaded, classifies every deficiency by type, and links each one to the data tables and studies it references.
Unity Catalog checks every item against your existing data automatically, flagging what's missing and saving weeks of back-and-forth.
50+ sensitivity analyses run simultaneously on Spark. MLflow audit trail for GxP reproducibility.
Safety data unifies across trials through a pre-built pipeline, with an AI-drafted narrative grounded in the actual dataset.
RegulatoryAI throughout the entire process.
Submission NDA 217045 Overview
Response deadline:
27 days remaining
RegulatoryAI — Retrieval-Augmented Assistant
Answers grounded in your NDA, CRL, and FDA guidances. All responses cite source documents.
RegulatoryAI drafts the response as the other stages finish, not after. Every line traces back to your NDA or FDA guidance
BUILT ON DATABRICKS
Every stage runs on the Databricks investment you already made.
No new platform. No migration. Every module runs on components already in your Lakehouse.
The same Lakehouse, doing more of the work that used to sit outside it.
Make your next CRL response take months, not a year.
Talk to our team about a 2-week proof of value on your own Databricks environment.