Agentic AI for Regulatory Affairs

Getting lifesaving drugs to patients faster

CMCNexus is an autonomous AI agent that converts raw lab and batch data into IND-ready CMC documents — cutting 12–14 months of manual effort down to weeks, and eliminating the errors that trigger costly FDA clinical holds.

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Raw Lab & Batch Data Ingested
Lab notebooks, stability reports, analytical data
Source
⚙️
CMC Document Drafted
Entity mapping, FDA regulatory templates applied
Drafting
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21 CFR Part 11 Validated
Compliance checked automatically before review
Validating
✅
IND-Ready for Scientist Review
Experts refine judgment — not formatting
Complete
~30%
Reduction in CMC preparation time through automated drafting & data retrieval
$8M
Per day in lost market opportunity — the cost of a single FDA clinical hold
~9%
Of INDs are placed on clinical hold; CMC errors are a leading cause
The Problem

Getting a drug into clinical trials takes far too long

The CMC section is a critical bottleneck: thousands of data points, months of manual effort, and a single error can halt an entire program.

01
Data Overload
The CMC section requires compiling thousands of data points from diverse sources — lab notebooks, batch records, analytical reports. Critical information is scattered, siloed, and unstructured.
02
Manual & Error-Prone
The process is highly manual, labor-intensive, and prone to human error — consuming countless hours of a highly specialized regulatory team. One inconsistency can be catastrophic.
03
High-Stakes Consequences
Errors, gaps, or inconsistencies in the CMC section can trigger an FDA clinical hold — putting the entire program at risk and triggering public scrutiny for large-cap companies.
12–14 mo
Months to Prepare a Single IND
Creating an IND application can take 12–14 months of painstaking, mostly manual preparation — time that could be spent advancing science and helping patients.
$8M/day
The Cost of a Clinical Hold
Errors, inconsistencies, or gaps in the CMC section can lead to an FDA clinical hold, costing up to $8 million per day in lost market opportunity for a top-tier drug.
~9%
INDs Placed on Clinical Hold
CMC-related issues are a leading cause of these holds — nearly all of them preventable with better data integrity, consistency checks, and validated workflows.
The Solution

From raw lab data to IND-ready CMC documents

CMCNexus is not a writing assistant. It is an autonomous orchestrator that manages, plans, retrieves, drafts, and validates the entire CMC lifecycle.

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01
Ingest Any Source Data
Pulls from lab notebooks, stability reports, batch records, and analytical data — structured or unstructured. No reformatting required before ingestion.
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02
Build the CMC Document
Drafts complex dossier sections automatically, mapping relationships between drug substance, drug product, manufacturers, and quality controls exactly as FDA templates require.
✅
03
Validate Against FDA Standards
Every output is checked against 21 CFR Part 11 requirements and the latest agency templates before the scientist sees it — compliance enforced automatically, every time.
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Scientists review and refine — not write from scratch. CMCNexus handles first-draft generation so your regulatory experts focus on scientific judgment. The human role shifts from author to reviewer, unlocking the highest-value work your team can do.

CMC Coverage

Complete field-level coverage of every CMC requirement

CMCNexus handles every required element of both the Drug Substance and Drug Product subsections — the full IND CMC checklist, automated end-to-end.

Drug Substance (Active Pharmaceutical Ingredient)
Identity & Characterization
Chemical name, code name, generic name; molecular structure & stereochemistry; physical properties (solubility, melting point, pH, crystalline/amorphous form)
Manufacturer
Site name, address, and production role for every manufacturing location
Manufacturing Process
Step-by-step process description, flow diagram with intermediates and control points, comprehensive raw material list (reagents, solvents, catalysts)
Quality Controls
Specifications and acceptance limits (e.g. purity >99.5%), test method descriptions (HPLC, UV spectroscopy), certificates of analysis from representative batches
Stability
Stability studies under temperature/humidity conditions, proposed shelf life, and recommended storage conditions
Drug Product (Finished Dosage Form)
Composition
Complete ingredient list (drug substance, excipients, manufacturing materials) with exact quantitative amounts per dosage unit
Manufacturing Process
Detailed step-by-step manufacturing and packaging description; process flow diagram with control points
Quality Controls
Potency, dissolution, and impurity specifications; analytical test methods; certificates of analysis from representative batches of the final product
Container / Closure System
Container and closure description; documented evidence of suitability and drug protection adequacy
Labeling & Environmental
Draft product, carton, and Investigator's Brochure labels; environmental impact statement (categorical exclusion where applicable)
Business Impact

Efficiency, accuracy, and speed to market

CMCNexus directly addresses the three core challenges of IND submissions — delivering a clear, measurable competitive advantage across every program in your pipeline.

Benefit
Without CMCNexus
With CMCNexus
⏱ Efficiency
12–14 months of manual data compilation, drafting, and cross-referencing. Countless hours of highly specialized team time consumed by formatting.
Automated drafting, data retrieval, and cross-referencing cuts preparation time by up to 70% — months reduced to weeks.
🎯 Accuracy
Manual data entry and writing lead to inconsistencies — a top cause of clinical holds and prolonged FDA information request cycles.
Secure knowledge graph ensures every data point is accurate and consistent across the entire document. Zero variance in output format.
🚀 Speed to Market
Clinical holds and prolonged timelines delay market entry, costing up to $8M per day — a figure that compounds across a large pipeline.
Common errors and inconsistencies prevented before submission, accelerating the path to First-in-Human trials and avoiding holds entirely.
Under the Hood

An agent that plans, retrieves, drafts, and validates

Given a high-level goal — "create the IND for Drug X for the treatment of Disease Y" — CMCNexus autonomously breaks it into sub-tasks and executes them end-to-end.

1
Internal Database Connector
Pulls specific data from your company's internal systems — EHRs, LIMS, lab notebooks, batch records — without any data leaving your network perimeter.
2
Document Generation Engine
Drafts CMC sections based on gathered data using approved regulatory templates and FDA-standard language. No formatting decisions delegated to humans.
3
Compliance Validator
Checks every draft against the latest FDA guidelines. A specialized, fine-tuned model continuously updated as new regulations and guidance documents are issued.
4
Data Cross-Referencer
Ensures data points referenced across sections are perfectly consistent — a claim in the non-clinical section is guaranteed to match the clinical section exactly.
Agent Persona
The Regulatory Dossier Manager
CMCNexus understands the end goal: a complete, compliant, and submission-ready IND or BLA. It doesn't just flag problems — it proactively generates clarification requests and suggests resolutions. It learns from every submission, getting better at anticipating what the FDA will ask next.
Project Manager Plans the workflow and orchestrates all sub-tasks autonomously
Technical Writer Generates precise, regulatory-grade document sections
QC Specialist Validates consistency and compliance before human review
HIPAA 21 CFR Part 11 On-Premise AI Full Audit Trail EMA & PMDA Ready Enterprise SSO
Built for Large Pharma

Four capabilities that matter at enterprise scale

CMCNexus is purpose-built for organizations where data sovereignty, audit readiness, and multi-program scale are non-negotiable requirements.

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Your data never leaves your network
All AI processing happens inside your own infrastructure. No molecule data, no batch records, no formulation IP sent to an external cloud. Built for teams where data sovereignty is non-negotiable.
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Full audit trail on every document
Every source document, every edit, every version is tracked. You know exactly where each claim came from — the right posture for FDA review, internal QA, and regulatory inspections.
⚖️
FDA-template compliance, enforced automatically
Documents are generated and validated against 21 CFR Part 11 and current FDA submission templates. No manual formatting, no variance across programs — audit-ready output every time.
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Designed to scale with your pipeline
Roadmap includes tailored outputs for EMA and PMDA, adaptive generation as guidance evolves, and enterprise SSO. Built for large, multi-program organizations with dozens of concurrent INDs.
Next Steps

A simple path to evaluation

We've designed our onboarding to give you a real, meaningful test of CMCNexus on your actual data — with no commitment and clear criteria.

1
30-min intro call
Walk through a live demonstration with your Regulatory Affairs team. See the agent work on a real CMC document from ingestion to output.
2
Pilot on one IND section
Test CMCNexus on a real document — no commitment, clear evaluation criteria defined upfront, full data security guaranteed.
3
Security & IT review
We support your full validation and data-governance review process, including GxP, 21 CFR Part 11 documentation, and enterprise security assessment.
4
Broader rollout
Deploy across programs with dedicated support for onboarding, training, and continuous improvement as your pipeline scales.
Ready to move faster

Do now what patients need next

See CMCNexus working on a real IND. Your data, your submission, your timeline — accelerated.

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