Coley, Inc.

Covered.

Every submission. Every label. Every report. Covered.

The Identity platform for pharmaceuticals and medical devices.

FDA submissions pressure-tested before filing. Marketing materials reviewed for off-label exposure. Adverse event reports designed to survive regulatory scrutiny. This is what the platform looks like in pharma.

Industries We Cover · Pharma Confidential · April 2026
Coley, Inc. · We read the room.
The Problem

Every claim is regulated. Every word is evidence.

Pharmaceutical and medical device companies produce documents that are read by the most sophisticated adversaries in any industry. FDA reviewers who know the regulations better than you do. Product liability attorneys building multi-district litigation. Qui tam relators and their counsel. State AGs running consumer protection investigations.

Promotional Compliance
Off-Label & Marketing Exposure
Every marketing claim, every sales aid, every speaker deck is reviewed for off-label promotion, unsubstantiated efficacy claims, and fair balance violations. A single promotional piece that crosses the line can trigger DOJ investigation, OIG exclusion, and multi-billion dollar settlements.
Regulatory Submissions
FDA Filing Precision
510(k)s, NDAs, BLAs, adverse event reports — every FDA submission is reviewed by scientists and regulators who will find what you got wrong. Incomplete adverse event reporting, inconsistent labeling language, or inadequate risk characterization can delay approval or trigger post-market enforcement.
Where each product is designed to help
Enterprise (Pharma / Device Operations)
Edge
Staff systems —
designed to protect
patient data in clinical
trials, CRO portals
Route
AI conversations —
HCP inquiries,
adverse event intake,
medical info requests
Comply
Back office —
adverse event reports,
FDA submissions,
audit-ready records
Audit
Legal —
marketing materials,
labeling, submissions,
adversarial review
A Day at the Company

A Wednesday at Cascade Therapeutics.

Mid-size specialty pharma. Three marketed products, two in the pipeline. Oncology and immunology. Every promotional piece, every FDA filing, and every adverse event report runs through regulatory frameworks enforced by the most sophisticated regulators in the world.

7:00 AM
Identity Audit™
The Sales Aid Review
Marketing has a new sales aid for the oncology product ready for the PRC meeting. Audit runs it from the perspective of an OPDP reviewer, a product liability plaintiff's attorney, and a state AG consumer protection investigator. Identified: a superiority claim on slide 4 that isn't supported by head-to-head data. The claim references a post-hoc subgroup analysis that OPDP has specifically flagged as inadequate for promotional superiority claims. Revised before the PRC sees it.
9:00 AM
Identity Edge™
The CRO Data Transfer
A clinical operations associate is emailing interim trial data to an external CRO partner. The spreadsheet includes patient identifiers, treatment assignments, and adverse event details. Edge is designed to identify the patient-level data at the keyboard — before it transmits outside the company's secure environment. The data goes through the validated secure file transfer system instead. The clinical trial integrity stays intact.
10:30 AM
Identity Route™
The HCP Inquiry That Crosses a Line
A physician contacts the medical information line: "I have a patient who failed two prior therapies. Can your product be used in combination with [off-label combination]?" Route reads the input: potential off-label use question, medical information request requiring scientific response, promotional boundary. Route escalates to the medical affairs team. The AI doesn't respond to off-label use questions. A medical science liaison does.
1:00 PM
Identity Comply™
The Adverse Event Report
Pharmacovigilance received 3 serious adverse event reports this week for the immunology product. Each has a 15-day expedited reporting deadline. Comply is designed to cross-reference each MedWatch report against FDA's reporting requirements, ensuring the narrative accurately characterizes the event, causality assessment is documented, and the report is consistent with the product's current labeling language. No gaps between what happened and what's reported.
3:00 PM
Identity Audit™
The Labeling Supplement
Regulatory affairs is preparing a labeling supplement to add a new safety warning. Audit runs the draft from the perspective of an FDA labeling reviewer, a product liability attorney, and a qui tam relator's counsel. Identified: the proposed warning language is narrower than what the clinical data supports. A plaintiff's attorney would argue the company knew the risk was broader than disclosed. The labeling is revised to match the data.
4:30 PM
Identity Comply™
The Sunshine Act Reporting
End of quarter. The company needs to report physician payments under the Sunshine Act. 847 transactions across speaker fees, consulting payments, and meal expenses. Comply is designed to cross-reference each transaction against CMS reporting categories, flagging inconsistencies between internal records and the Open Payments database format. Clean data. Clean filing. No surprises when the database goes public.
The Numbers

One company. Four products. Potential impact.

~200
Promotional pieces reviewed per year through PRC.
100%
Marketing materials designed to be reviewed before HCP distribution.
15 days
Expedited AE reporting deadline. Every narrative matters.
$0
Outside counsel needed for routine promotional review.
The math on off-label exposure.
DOJ off-label settlements average $500M–$3B. A single OPDP untitled letter can halt a promotional campaign. A qui tam action under the False Claims Act exposes the company to treble damages plus $11K per false claim. The cost of Audit is less than one hour of the FDA regulatory counsel you're currently paying.
Why Pharma

Why pharma is a natural fit.

Every promotional claim is a regulatory event
Sales aids, speaker decks, digital campaigns, social media posts — every claim about a product is subject to FDA oversight. OPDP reviews promotional materials and issues warning letters that become public. One bad claim can shut down a campaign and trigger a DOJ referral.
Product liability is the long tail
Labeling, warnings, adverse event reports — product liability attorneys use these documents to build cases years after the product launched. What you knew, when you knew it, and how you characterized the risk is the entire ballgame in failure-to-warn litigation.
Qui tam relators are watching
Former employees, sales reps, and HCPs who see off-label promotion or kickback schemes can file False Claims Act suits. The financial incentive for relators is enormous. Every internal document is a potential qui tam exhibit.
California adds another layer
Prop 65 cancer and reproductive harm warnings, California's Unfair Competition Law (UCL) for marketing claims, and CCPA for clinical trial participant data — companies operating in California face state-level requirements on top of federal FDA oversight.
"The cost of Audit is less than one hour of the FDA regulatory counsel you're currently paying."
Pilot Terms

Try it. For free. On your documents.

The 30-Day Pilot
Give us 3 promotional pieces and 2 labeling documents. We run them through Audit for free over 30 days.
If the findings identify regulatory exposure your PRC process missed, we talk pricing.
Audit
3 promotional pieces reviewed for off-label, fair balance, and OPDP exposure
Audit
2 labeling documents pressure-tested for regulatory and liability exposure
Start a Pilot
No integration. No contract. No risk.
Just your documents, and our findings.
Platform Context

This is one industry. The platform extends.

Pharma is one deployment. The same architecture is designed to serve healthcare, banking, insurance — any domain where compliance pressure meets operational complexity.

Edge
Active
Route
Active
Comply
Active
Audit
Active
Locker
Industries We Cover
Banking Healthcare Government Education Insurance Pharmaceuticals General Legal
Covered.
A Coley, Inc. industry deployment
"We read the room. And protect everyone in it."
Patent pending · getcoley.ai · Confidential
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