Commercial Compliance · U.S. Privacy · HIPAA · AI Governance

Compliance built for the business of life sciences.

Senior-led compliance for pharma, biotech, and medical-device companies — with AI-enhanced tools generalist firms can’t match.

TRESTLE support represented by two people connecting across a bridge
Founder-led, relationship-drivenLife-sciences compliance experience
Senior counsel from day oneEvery engagement is founder-led.
Built for life sciencesNo generalist learning curve on your matter.
Practical, evidence-linked workDesigned for teams, boards, and regulators.
TRESTLE Compliance

Supporting the Business of Life Sciences

The TRESTLE Proposition

A specialist firm with tools the generalists don't have.

TRESTLE pairs 25+ years of life-sciences compliance leadership with proprietary tools that make complex work faster, clearer, and easier to operationalize. Clients receive senior judgment and practical evidence—not layers of junior staffing.

Greater Value

Senior expertise, not associate hours.

Every engagement is led directly by the founder — a JD/MBA former Chief Compliance Officer with pharma, biotech, and diligence experience. Partner-level thinking at a specialist-boutique rate, not a large-firm leverage model.

Greater Effectiveness

Life-sciences-specific from day one.

Comprehensive state privacy laws include HIPAA carve-outs, research exemptions, and employee-data provisions that generalist firms often miss. We scope per data stream, not per company — the level of granularity diligence and enforcement now demand.

Greater Efficiency

AI-enhanced tooling built in.

The TRESTLE Privacy Console™ and TRESTLE Regulatory Radar™ shorten every engagement. Scoping that took a week now takes an afternoon; regulatory monitoring that took a quarterly memo now runs continuously in a live reference your team can open on any device.

The TRESTLE Product Suite

Six proprietary tools. One integrated compliance program.

Every TRESTLE engagement is powered by our own AI-enhanced product suite — built for life-sciences compliance teams who need transparent methodology, audit-ready outputs, and tools generalist firms don't offer.

Inspiring Integrity by L. Stephan Vincze
Anchored in Inspiring Integrity
The TRESTLE thesis on why integrity is a business asset in life sciences — and the operating model every tool below is built to serve. See the Integrity System →

TRESTLE Regulatory Radar

A live interactive reference of 63 U.S. federal, state, and cross-border requirements across 28 jurisdictions — comprehensive state privacy, HIPAA, AI governance, cybersecurity, FTC enforcement, consumer-health-data, biometric, and research/clinical rules. Filter by state, obligation, or trigger — refreshed monthly on the 1st.

Open live radar

TRESTLE Privacy Console

A branded client-facing portal that mirrors every engagement in real time — document register, findings, data-flow inventory, milestone timeline, and deliverables.

See the Console

TRESTLE FMV

Subscription-grade fair-market-value rates for U.S. healthcare professionals. Stark-anchored, transparent methodology, priced well below legacy FMV vendors.

Try the demo

The TRESTLE AI Integrity Test

A board-ready diagnostic across 14 scored instruments in 4 dimensions — is your AI governed, on the record, today? Anchored in DOJ ECCP, FDA AI guidance, EU AI Act, and OIG.

See the diagnostic

TRESTLE AI Integrity Framework

The complete governance methodology the AI Integrity Test™ is built on — policies, controls, evidence library, and audit-ready documentation across the AI lifecycle.

Explore the Framework
In development

TRESTLE Praxis

Our next-generation integrated compliance platform — unifying Radar™, Console™, FMV™, and the AI Integrity Framework™ in one intelligent workspace. Design partners wanted.

Preview the concept
What clients say

Trusted by the people who know the nuance

“When it comes to ensuring a healthy corporate culture — one that understands and respects the business value of compliance — Steve Vincze is the go-to professional.”

Rich Daly, President & CEO, Catalyst Pharmaceuticals

“Steve and TRESTLE played an important role in our compliance department, providing sound and practical advice whenever asked. Their professionalism is outstanding.”

Jocelyn Lafond, LL.B., LL.M., Former General Counsel & Corporate Secretary, Theratechnologies

“Spot on.”

Brian Elsbernd, Chief Legal Officer & Chief Compliance Officer, Catalyst Pharmaceuticals

“This is exactly what we needed.”

Ellen Gettenberg, SVP, Commercial Operations, Theratechnologies
How we can help

Start with the business question in front of you.

Whether you are preparing to launch, strengthening an established program, or navigating a new privacy or AI risk, TRESTLE meets you where the work is.

Build & prepare

Get launch- and transaction-ready.

Design or strengthen a right-sized compliance program that supports commercial goals and stands up to diligence.

Explore commercial compliance →
Protect & prove

Turn complex data obligations into action.

Map data streams, prioritize state and federal requirements, and create evidence your team can use.

Explore privacy & HIPAA →
Govern & grow

Adopt AI with confidence.

Assess risk, establish a practical governance framework, and prepare leadership for responsible adoption.

Explore AI governance →
See all ways to work with TRESTLE
Three Practice Pillars

Deep expertise across the compliance domains that matter to life sciences.

Commercial Compliance

Effective compliance programs, designed and proven.

Programs built on the OIG’s seven elements and the DOJ’s three fundamental questions — designed, implemented, operated, trained, monitored, audited, and remediated across the full life-sciences life cycle.

Explore Commercial Compliance →
U.S. Privacy & HIPAA

Right-sized privacy programs, per data stream.

State comprehensive privacy laws carry HIPAA carve-outs, research exemptions, and employee-data provisions generalists miss — so we scope per data stream, not per company.

Explore U.S. Privacy & HIPAA →
AI Governance

Diagnose → Adopt → Operationalize.

Three proprietary assets under one umbrella — The TRESTLE AI Integrity Test™ to diagnose, the TRESTLE AI Integrity Framework™ to adopt, and TRESTLE Praxis™ to operationalize.

Explore AI Governance →
The working experience

Senior guidance without unnecessary friction.

You work directly with people who understand both the regulation and the business it must support.

Start with the real question

We listen first and define the decision, risk, or deadline that matters now.

Right-size the response

No oversized team or generic playbook—only the expertise and tools the situation requires.

Build usable evidence

Clear outputs your operational teams, leadership, board, and regulators can understand.

Stay supported

Scale advisory help up or down as the company, program, and requirements evolve.

L. Stephan Vincze, Founder, President & CEO of TRESTLE Compliance
25+ years
Healthcare & life sciences
Leadership

L. Stephan Vincze, JD, MBA

Founder, President & CEO

A recognized legal and compliance expert with 25+ years in the healthcare and life sciences industry who has engaged directly with the OIG, FDA, DOJ, and Congress — including landmark enforcement matters. Former Chief Compliance Officer with pharma, biotech, and diligence experience.

Author of Inspiring Integrity: How to Win with Compliance and Propel Performance.

Work with Steve
Thought Leadership

Insight that puts integrity to work

01Read
Inspiring Integrity: How to Win with Compliance and Propel Performance, by L. Stephan Vincze
The Book

Inspiring Integrity — the thesis behind every TRESTLE tool

Compliance leaders keep getting handed the same brief: do more, with less, under harder scrutiny. Inspiring Integrity is Steve Vincze’s answer — a five-part operating model for turning integrity into principled performance and measurable business advantage. It is also the intellectual foundation of the TRESTLE Product Suite: every tool below expresses one of the five moves the book lays out.

The Inspiring Integrity Workshop™ installs that model in your leadership team — a five-part teaching format that anchors the AI Integrity Test™, Framework™, and every downstream engagement:

  1. 1 Define success as principled performance
  2. 2 Make strategy shared, not siloed
  3. 3 Lead culture, not just controls
  4. 4 Execute collaboratively at operating speed
  5. 5 Measure trust and performance together
1-hour briefing2-hour workshopHalf-dayFull-day

Praised by Meenakshi Datta (Partner, Sidley) and Kathleen Coffey (CEO & Board Member).

02Download
Whitepaper cover: AI Governance in Life Sciences — What FDA, OIG, and DOJ Now Expect, by L. Stephan Vincze, TRESTLE Compliance
Featured Brief

Three agencies. One direction of travel.

In eighteen months, FDA, HHS-OIG, and DOJ each told life sciences leaders what good AI governance looks like — and their messages converge. This brief synthesizes what each now expects, and what a natural compliance extension looks like in practice.

  • What FDA, HHS-OIG, and DOJ each now expect of AI use
  • The five expectations that recur across all three agencies
  • A directional 90-day agenda compliance leaders can begin now
Request the brief
03Follow
Live on LinkedIn

Featured posts — from Steve’s LinkedIn

Steve regularly publishes on the topics that drive TRESTLE’s work — AI governance, U.S. privacy and HIPAA, life-sciences compliance, and integrity in leadership. His LinkedIn Featured section is the fastest way to see what he is watching, writing, and speaking about right now.

  • Recent commentary on FDA, OIG, and DOJ AI expectations
  • Regulatory recognitions and speaking engagements
  • Highlights from Inspiring Integrity and TRESTLE product launches
Next Step

Let’s start with a practical conversation.

Bring the question that is keeping you up at night. In 30 minutes, we can look at your footprint, open the live Regulatory Radar™, and identify a sensible next step — with no obligation and no hard sell.

Share the issue you are facing and the best way to reach you. A senior TRESTLE advisor will respond directly.