COMMERCIAL & PROMOTIONAL COMPLIANCE

PROMOTIONAL COMPLIANCE & REGULATORY READINESS

Approval is not the end of the story.

Approval is not the
end of the story.

The risk is the whole thread.


PromoCX connects promotional review, digital and channel monitoring, structured assessments, and agency-ready packaging

on a single compliance backbone — so the evidence chain that informed approval is the same one that informs what you monitor, measure, and file.


The backbone is a shared rule library with regulatory lineage, explainable findings, consistent findings scoring, and an audit trail — not a patchwork

of tools rebuilt at every handoff.

The root cause is upstream evidence that never carried forward.

RegIQ connects supplier CoAs, batch records, and CAPA findings to regulatory submission on a single compliance

backbone — so the evidence chain that informed quality decisions is the same one that informs what gets filed.


The backbone is a shared rule library, citeable regulatory references, FIVES scoring, and a continuous audit trail

— running from supply chain through submission, not rebuilt at each handoff.

The root cause is upstream evidence that never carried forward.

RegIQ connects supplier CoAs, batch records, and CAPA findings to regulatory

submission on a single compliance backbone — so the evidence chain that

informed quality decisions is the same one that informs what gets filed.


The backbone is a shared rule library, citeable regulatory references, FIVES scoring,

and a continuous audit trail — running from supply chain through submission, not

rebuilt at each handoff.

The Problem Worth Solving

The Problem Worth Solving

Compliance breaks at handoffs

Brand, marketing, medical, legal, and regulatory teams use different systems for review,

web, social, and submissions. The same story is re-told manually at every boundary.



Live channels outpace static approvals

Websites and digital campaigns change after approval. Without continuous checks and

explainable findings, teams discover gaps late — when the risk is already public.



Agency pressure without a single thread

When regulators ask questions, teams rebuild the narrative from emails and files.

What should be inspection-ready is often assembled under time pressure.

Compliance breaks at handoffs

Brand, marketing, medical, legal, and regulatory teams use different systems for review,

web, social, and submissions. The same story is re-told manually at every boundary.



Live channels outpace static approvals

Websites and digital campaigns change after approval. Without continuous checks and

explainable findings, teams discover gaps late — when the risk is already public.



Agency pressure without a single thread

When regulators ask questions, teams rebuild the narrative from emails and files.

What should be inspection-ready is often assembled under time pressure.

How PromoCX Works —
Content to Channels to Regulators

Business Outcomes —
Who It Benefits

  1. Review & Collaborate

Medical–legal review with

explainable AI

Structured review workflows for promotional and

scientific content — with AI-assisted screening,

human decisions where they belong, and clear

rationale teams can defend.

Collaboration and review history stay attached to the

content, not lost in inboxes.

Medical–Legal Review Brand & marketing

  1. Assess Web Properties

Technology compliance for

owned sites

Executive-ready assessment of brand and corporate

web properties — accessibility, consistency, and

technology risk surfaced in language leadership and

digital owners already use.

Addresses what visitors experience on domains you

control — a different risk surface than social, and a

different conversation with leadership.

Technology Compliance Digital & IT

Clinical Data Quality Clinical Supply Chain

Patient Recruitment Clinical Data Integration

Clinical operations

  1. Monitor Live Channels

Social and executional monitoring

Ongoing visibility into promotional and brand

execution across social and digital channels — so

teams see what is live in market, not only what was

approved in MLR.

Different buyers and workflows than web-property

assessment: brand guardians and promo ops tracking

executional drift and channel-specific risk.

Social & Channel Monitoring Brand & promo ops

  1. Evaluate Materials

Broadcast & direct-to-consumer

TMF, contracts, DMC, CRO

oversight

Structured assessments for promotional and DTC-style

content on a consistent framework — not ad hoc

checklists. The same dimensions apply across every

piece: claims and presentations of efficacy and safety,

fair balance and important safety information,

alignment to approved labeling, and substantiation

discipline.

Teams compare campaigns and revisions on one

rubric — gaps in balance, claims, or evidence surface

before materials scale.

Broadcast & DTC Promotional operations

Safety Event Triage Adverse Event Reporting

Protocol Deviation Mgmt Corrective Action

Safety & quality

  1. Package & Respond

Submissions, labeling support,

and agency correspondence

Workflows to support FDA submissions and annotated

labeling where your process requires them — with

validation and packaging that reduce last-minute

rework. Structured response packages for agency

correspondence — findings, citations, and corrective

intent documented in one place.

What should be inspection-ready is built as you work,

not assembled at the deadline.

Your validated policies and procedures remain yours

— PromoCX aligns evidence and checks to the same

rule model end to end.


Submissions & Labeling

Agency Correspondence Regulatory affairs

  1. CLOSE THE LOOP

Corrective action when it matters

Route issues from monitoring and review into

corrective and preventive workflows — with context

preserved so remediation addresses root cause, not

symptoms.

Builds the compliance trail continuously — not

reconstructed when Legal or FDA ask.

Corrective Action Quality & compliance

Outcomes — Who It Benefits

BRAND & MARKETING

Faster confidence in

what ships

Faster confidence in what ships

Review and channel visibility on one

thread — fewer surprises after approval

Review and channel visibility on one thread — fewer surprises

after approval

REGULATORY & MEDICAL AFFAIRS

Defensible evidence, not

reconstructed files

Defensible evidence, not reconstructed files

Citations and decisions traceable from

content to monitoring to filing

Citations and decisions traceable from content to monitoring to filing

Expedited deadlines, immutable signed records, and

deviation-to-CAPA traceability that matches inspector expectations

LEGAL & COMPLIANCE

Less firefighting when

agencies ask

Less firefighting when agencies ask

Structured packages and audit trails

— built as you work, not assembled at

the deadline

Structured packages and audit trails — built as you work, not assembled

at the deadline.

What Leaders Recognize

Illustrative composite quotes for positioning — not attributed to named customers unless separately approved.

Illustrative composite quotes for positioning — not attributed to named

customers unless separately approved.

“We don’t need another silo. We need the same

compliance language from MLR through what’s

live online — and into what we file.”

VP, Regulatory Operations — global pharma

“If it can’t show the rule and the why, it doesn’t

help when Legal or FDA ask.”

VP, Commercial Compliance

“The risk isn’t only the slide deck. It’s the website,

the social post, and the letter we have to answer.”

Chief Compliance Officer — life sciences

Compliance is infrastructure. Automation without citeable rules and lineage is not defensible in audit — or when the agency asks for the thread.

22 capability divisions. One compliance backbone.

Compliance is infrastructure.

Automation without citeable rules and lineage is not defensible in audit — or when the agency asks for the thread.

22 capability divisions. One compliance backbone.

Compliance is infrastructure.

Automation without citeable rules and lineage is not

defensible in audit — or when the agency asks for the thread.

22 capability divisions. One compliance backbone.

Seven capability areas. One compliance backbone.

Seven capability areas.
One compliance backbone.

Each area on the same rule model and audit trail.

  1. Medical–Legal Review

Workflows for promotional and scientific content with

AI-assisted screening, collaboration, and audit trails

  1. Technology Compliance

Website and digital property assessments with

executive-ready reporting — accessibility and risk

in business language

  1. Social & Channel Monitoring

Visibility into what runs in market — aligned to your

compliance program

  1. Broadcast & DTC

Structured assessments for promotional and

direct-to-consumer materials on a consistent claims

and fair-balance framework

  1. Submissions & Labeling Support

  1. Submissions & Labeling
    Support

Support for FDA submission workflows and annotated

labeling where your process requires them

  1. Agency Correspondence

  1. Regulatory Submission
    Tracking

Structured response packages for regulatory letters

— findings and context in one place

  1. Corrective Action & CAPA

Close the loop from review and monitoring into

corrective workflows — context preserved,

remediation tied back to findings, not orphaned tickets

Additional commercial and medical modules — scope and roadmap available on request. Product names and entitlement scope confirmed under agreement.

Additional commercial and medical modules — scope and roadmap available on request.

Product names and entitlement scope confirmed under agreement.

Additional commercial and medical modules — scope and roadmap available on request.

Product names and entitlement scope confirmed under agreement.

See The Thread On Your Roadmap

See The Thread On
Your Roadmap

We’ll walk through how PromoCX connects the compliance work you already do — from review to live channels to regulatory readiness — and where it fits alongside your existing tools.

No generic slide deck: bring your current process and we’ll map it.

We’ll walk through how PromoCX connects the compliance work you already do — from

review to live channels to regulatory readiness — and where it fits alongside your existing tools.

No generic slide deck: bring your current process and we’ll map it.