MEDICAL AFFAIRS & SAFETY COMPLIANCE

Medical Affairs is not a cost center
waiting for the next approval cycle.

The risk is the whole thread.


From real-world signal and scientific exchange to what the field communicates, to what Legal and regulators

must reconstruct — that path is one thread. When it fragments, inspection and deal narratives fragment with it.


Medical Affairs & Safety from TFives is one compliance backbone: the same governed objects and citations

from first signal through MSL and Medical Affairs use to submission-ready documentation — not a patchwork

of slides, inboxes, and tools rebuilt at every handoff.


For consumer health, the regulatory frame is explicit: FTC substantiation for advertising and promotional claims;

FDA where OTC monograph and Drug Facts labeling apply; WCAG 2.1 AA for patient- and HCP-facing digital surfaces.

The compliance backbone carries rule lineage so those dimensions stay traceable — not retrofitted after the fact.

The risk is the whole thread.


From real-world signal and scientific exchange to what the field communicates, to what

Legal and regulators must reconstruct — that path is one thread. When it fragments,

inspection and deal narratives fragment with it.


Medical Affairs & Safety from TFives is one compliance backbone: the same governed

objects and citations from first signal through MSL and Medical Affairs use to

submission-ready documentation — not a patchwork of slides, inboxes, and tools

rebuilt at every handoff.


For consumer health, the regulatory frame is explicit: FTC substantiation for advertising

and promotional claims; FDA where OTC monograph and Drug Facts labeling apply;

WCAG 2.1 AA for patient- and HCP-facing digital surfaces. The compliance backbone

arries rule lineage so those dimensions stay traceable — not retrofitted after the fact.

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The Problem Worth Solving

The Problem Worth Solving

Data without a defensible chain

The gap between “we have data” and “we can show Legal why we said it” is where teams

stall: analyses outpace binding to compliant field use, and inspection narratives fracture.



Consumer health is not prescription pharma

FTC governs advertising truthfulness and substantiation. FDA anchors OTC Drug Facts and

monograph alignment — not a prescription fair-balance deck alone. Accessibility is a compliance

surface, not a design preference.



Handoffs without a single thread

When the question comes, teams should not reconstruct the story from email. What must be

inspection-ready should be built as the work proceeds — same objects, same lineage, end to end.

Data without a defensible chain

The gap between “we have data” and “we can show Legal why we said it” is where

teams stall: analyses outpace binding to compliant field use, and inspection narratives

fracture.



Consumer health is not prescription pharma

FTC governs advertising truthfulness and substantiation. FDA anchors OTC Drug Facts

and monograph alignment — not a prescription fair-balance deck alone. Accessibility

is a compliance surface, not a design preference.



Handoffs without a single thread

When the question comes, teams should not reconstruct the story from email.

What must be inspection-ready should be built as the work proceeds — same objects,

same lineage, end to end.

How Medical Affairs & Safety Works — Signal to field to audit

How Medical Affairs & Safety
Works — Signal to field to audit

How Medical Affairs & Safety Works
— Signal to field to audit

Five beats on one compliance backbone. Your policies and procedures remain yours; TFives aligns evidence, personas, and documentation to a consistent rule model.

Five beats on one compliance backbone. Your policies and procedures remain

yours; TFives aligns evidence, personas, and documentation to a consistent rule model.

Five beats on one compliance backbone. Your policies and procedures remain yours;

TFives aligns evidence, personas, and documentation to a consistent rule model.

PLAN

Signal and context before the deck

Pharmacy, adherence, and safety signals attach as governed objects — not as orphaned extracts. What the field will reference is

created once, traceably.

Pharmacy, adherence, and safety signals attach as governed

objects — not as orphaned extracts. What the field will reference is

created once, traceably.

Pharmacy, adherence, and safety signals attach as governed objects — not as orphaned

extracts. What the field will reference is created once, traceably.

RWE & signals Medical Affairs

SYNTHESIZE

Evidence packages tied to citations

Rapid-cycle synthesis, patient-level views, and study design artifacts share one compliance envelope — claims, cuts, and references

aligned to what review and audit will ask for.

Rapid-cycle synthesis, patient-level views, and study design

artifacts share one compliance envelope — claims, cuts, and

references aligned to what review and audit will ask for.

Rapid-cycle synthesis, patient-level views, and study design artifacts share one compliance

envelope — claims, cuts, and references aligned to what review and audit will ask for.

Evidence synthesis HEOR

ENGAGE

Scientific exchange and KOL alignment

Briefings and field coordination draw from the same evidence graph — keeping the scientific exchange narrative consistent with what

compliance and regulatory will see — and what inspection will ask for.

Briefings and field coordination draw from the same evidence

graph — keeping the scientific exchange narrative consistent with what

compliance and regulatory will see — and what inspection will ask for.

Briefings and field coordination draw from the same evidence graph — keeping the scientific

exchange narrative consistent with what compliance and regulatory will see — and what inspection will ask for.

Scientific exchange MSL & KOL

ACT

Care gap and orchestration under guardrails

Interventions and journeys inherit the same boundaries: each persona sees what policy permits; Compliance retains lineage across

the full path.

Interventions and journeys inherit the same boundaries: each

persona sees what policy permits; Compliance retains lineage

across the full path.

Interventions and journeys inherit the same boundaries: each persona sees what policy permits;

Compliance retains lineage across the full path.

Orchestration Compliance

PROVE

Audit-ready documentation by construction

Export and handoff match what was reviewed — not a second reconstruction under time pressure. The thread that informed field use

is the thread you file and defend.

Export and handoff match what was reviewed — not a second

reconstruction under time pressure. The thread that informed field

use is the thread you file and defend.

Export and handoff match what was reviewed — not a second reconstruction under time pressure.

The thread that informed field use is the thread you file and defend.

ENTERPRISE PROGRAMS

SEE WHAT APPLIES

Rules Intelligence — one library, whole lifecycle

When a team needs to show why a control applies — from development through post-market vigilance — Rules Intelligence surfaces

the relevant obligations from the L1–L5 hierarchy in one place instead of reconciling separate rulebooks by hand.


The same rule that governs a development-stage AI check governs the post-market vigilance obligation — one corpus, consistent lineage.

Exact modules and rule coverage depend on your program configuration. Scope confirmed under agreement.

When a team needs to show why a control applies — from

development through post-market vigilance — Rules Intelligence

surfaces the relevant obligations from the L1–L5 hierarchy in one

place instead of reconciling separate rulebooks by hand.


The same rule that governs a development-stage AI check governs

the post-market vigilance obligation — one corpus, consistent lineage.

Exact modules and rule coverage depend on your program configuration.

Scope confirmed under agreement.

When a team needs to show why a control applies — from development through post-market

vigilance — Rules Intelligence surfaces the relevant obligations from the L1–L5 hierarchy in one

place instead of reconciling separate rulebooks by hand.


The same rule that governs a development-stage AI check governs the post-market vigilance

obligation — one corpus, consistent lineage.


Exact modules and rule coverage depend on your program configuration. Scope confirmed under agreement.

Audit & documentation Regulatory affairs

Outcomes — Who It Benefits

MSL & FIELD MEDICAL

One thread from evidence

to execution

Faster confidence in what ships

One thread from evidence to execution

Talking points and materials aligned to

governed sources — fewer late

reconciliations before customer-facing use

Talking points and materials aligned to governed sources — fewer late

reconciliations before customer-facing use

MEDICAL AFFAIRS LEADERSHIP

Strategy with a defensible

chain

Defensible evidence, not reconstructed files

Strategy with a defensible chain

Outcomes, publications, and contracting

narratives anchored to the same objects

and citations

Expedited deadlines, immutable signed records, and

deviation-to-CAPA traceability that matches inspector expectations

Outcomes, publications, and contracting narratives anchored to the same

objects and citations

LEGAL & COMPLIANCE

Rule lineage before the

question

Less firefighting when agencies ask

Rule lineage before the question

FTC, FDA OTC, and WCAG posture explicit

in the compliance backbone — not argued

after materials ship

FTC, FDA OTC, and WCAG posture explicit in the compliance backbone

— not argued after materials ship

What Leaders Recognize

What Leaders Recognize

“We needed one compliance language from signal

through the field — and into what we file. Not

another dashboard that stops at the slide.”

VP, Medical Affairs — consumer health

“If it cannot show the rule and the rationale on

consumer-facing surfaces, it does not survive our

first review. Here that line is visible before spend,

not after.”

Chief Compliance Officer — OTC / self-care

“The value was not a demo. It was the same

package the MSL used, the same citations Legal

saw, and the same export regulatory received —

without a parallel rebuild.”

Head of Scientific Engagement

Compliance is infrastructure. Automation without explainable regulatory context is hard to defend — and hard to operationalize across teams.

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 explainable

regulatory context is hard to defend — and hard to operationalize across teams.

Five capability areas. One compliance backbone.

Five capability areas.
One compliance backbone.

Each area corresponds to one beat in the thread above — one compliance backbone, summarized for quick reference.

  1. Plan — signal & context

Governed RWE and care-gap signals created once,

traceably, before the deck.

  1. Synthesize — evidence &
    citations

Rapid-cycle and study artifacts in one compliance

envelope; claims aligned to review and audit.

  1. Engage — scientific exchange

MSL and KOL alignment from the same evidence

graph; narrative consistent through inspection

questions.

  1. Act — orchestration

Interventions and journeys under persona guardrails;

Compliance retains full lineage.

  1. Prove — audit & handoff

  1. Submissions & Labeling
    Support

Export matches review; submission-ready

documentation without parallel rebuild.

See it on your scenario

See The Thread On
Your Roadmap

Bring a real KOL name, a real brand tension, or a real care-gap signal. We map the thread: evidence, field use, audit posture — on your facts, not a generic storyline.

Bring a real KOL name, a real brand tension, or a real care-gap signal.

We map the thread: evidence, field use, audit posture — on your facts,

not a generic storyline.

Bring a real KOL name, a real brand tension, or a real care-gap signal. We map the thread: evidence, field use,

audit posture — on your facts, not a generic storyline.

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