Services

How we work with life-sciences companies.

Every engagement sits on one framework, offered as a five-tier ladder — from an always-on Regulatory Radar™ subscription to ongoing Advisory Support to a fractional Chief Compliance, Privacy, or AI Integrity Officer. Across those tiers, three deep practice pillars carry the work: Commercial Compliance, U.S. Privacy & HIPAA, and AI Governance.

1 2 3 4 5 Foundation Assessment Build Out Advisory Fractional
The Ladder

Five tiers. One framework.

Services are packaged as five tiers — from a lightweight always-on Radar™ subscription, through ongoing Advisory Support, to a fractional Chief Compliance / Privacy / AI Integrity Officer engagement. Every tier sits on the same underlying framework, so clients can move up or down as needs and headcount evolve.

1
Foundation

Regulatory Radar™

Always-on monthly refresh of every U.S. federal and state law affecting life-sciences data operations, plus on-call questions.

  • 63 requirements across 28 jurisdictions
  • Plain-English summaries + per-function action items
  • Quarterly refresh & delta memo
  • Client-tenanted view of the WS matrix
Best forLegal, compliance, or privacy leads who need current visibility without a large engagement.
2
Assessment

Program Assessment

A 6–8 week state-privacy program-gap review, scoped per data stream, that produces a board-ready findings package.

  • Interview log, evidence pack, and R-ID-tagged risk matrix
  • HIPAA & state-privacy scoping per data stream
  • Executive deck & findings memo
  • Priority / Action / Plan settlement of every finding
Best forCompanies preparing for diligence, an audit, an OIG matter, or a substantive program overhaul.
3
Build Out

Program Build Out

Right-sized Commercial Compliance, U.S. Privacy & HIPAA policies, SOPs, training package, templates, and checklists — tailored to your operating model.

  • Policy suite & SOP library
  • Role-based training curriculum
  • DSR, BAA, vendor, and DPA templates
  • Optional GDPR & AI Governance overlays
Best forOrganizations that have a scoped program plan and need to stand it up (policies, SOPs, training, templates).
4
Advisory

Advisory Support

Ongoing counsel without officer-level coverage — a senior compliance sounding board on retainer, sized to the questions in front of you this quarter.

  • Retainer hours, used across privacy, commercial, and AI governance
  • Regulatory questions, policy reviews, and gray-area calls
  • Board / audit-committee prep as needed
  • Escalation path when a matter warrants formal engagement
Best forCompanies with an in-house owner who needs a senior second opinion — not a named officer, not a project, just steady access.
5
Fractional

Fractional CCO / CPO / CAIO

Monthly advisory, on-call regulatory response, and named-officer coverage — the operational muscle of a compliance department at a fraction of the cost.

  • Named Chief Compliance, Chief Privacy, or Chief AI Integrity Officer
  • Monthly advisory + on-call response
  • Board and audit-committee reporting
  • AI governance advisory, grounded in human judgment
Best forGrowth-stage companies that need officer-level coverage without a full-time hire, or bridging capacity.

Same framework, five entry points. Clients move up or down as needs evolve. Every tier includes the Regulatory Radar™ live reference — refreshed monthly, walkable before we meet.

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 →
Specialized & Advisory Services

Engaged where the stakes are highest

Beyond the five-tier ladder, TRESTLE takes on focused, high-value engagements — drawing on 25+ years in healthcare and life sciences, and direct engagement with the OIG, FDA, DOJ, and Congress.

M&A & PE Due Diligence

Transaction-readiness, buy- and sell-side compliance diligence, and post-close remediation. Evidence-linked deliverables that hold up under acquirer scrutiny.

GDPR & Cross-Border Transfers

SCC library, DPA templates, RoPA (Art. 30), DPIA methodology, TIA framework, EU-rep positioning, and US-sub / EU DPO coordination for life-sciences groups.

Customized Training

Role-based programs across commercial, corporate, U.S. Privacy, HIPAA, GDPR, and AI Governance — tailored curricula for Boards, Executive Teams, and Employees. Delivered with creative video and story-telling so principles are remembered, not just documented — audit-ready and measurable.

Compliance Expert & CIA / IRO

Independent compliance expert support and CIA / IRO services for complex regulatory, enforcement, and monitoring matters. An operational complement to your legal counsel, not a substitute.

TRESTLE FMV™ — Fair Market Value

TRESTLE FMV™ is our subscription-grade fair-market-value platform for HCP / KOL arrangements, speaker and advisory fees, and consulting engagements — Stark-anchored, transparent methodology, audit-ready outputs. Solo, Team, and Enterprise tiers, with optional international pack (EU5, UK, Japan, Canada) and FMV opinion letter add-ons. Request a scoping call.

Independent Annual Compliance Audits

Objective, third-party annual audits of your compliance program — testing the seven elements, field and commercial practices, and HIPAA/privacy controls — with a prioritized remediation roadmap for the board and audit committee.

Speaking, Hosting & Workshops

Keynotes, conference hosting and moderation, board and executive workshops, and the Inspiring Integrity Workshop™ — bringing a recognized compliance voice to your event or leadership team.

Next Step

Tell us where your program is today.

Whether you are building, strengthening, or temporarily leading a program, we can identify the right-sized level of support in one practical conversation.