Built for Speed In Complex, Highly Regulated Industries

Implementing compliance programs that support — not stunt – commercial growth.

• Right-Sized Program Design: Create compliance frameworks tailored to your stage—from early startup to commercial-stage growth.
• Operational Integration: Embed compliance into finance, sales, and product workflows—so it actually works.
• Policies & SOPs That Reflect Reality: Practical documentation aligned with how your teams operate.
• Commercial Model Design: Capital sales, leases, subscriptions, and pay-per-use models aligned with AKS, FDA, and reimbursement dynamics.
• Training Specific for Departmental Teams: Focused, role-based training on FDA, AKS, and privacy risk areas that are designed so that everyone – from engineers, to sales teams, to Board members –understand their corporate obligations.
• Ongoing Advisory & Embedded Support: Day-to-day guidance as your business evolves and quick, practical advice to address urgent “fire drills.”

Translating complex fraud and abuse laws into scalable processes tailored to your business.

• De-Risk Your Commercial Model: Identify Anti-Kickback Statute (AKS), Stark Law, and OIG risk across capital sales, consumables, rentals, and per-use structures.
• Structure Deals That Hold Up: Build compliant frameworks aligned with AKS safe harbors, OIG guidance, and real-world sales execution.
• Defensible Pricing & FMV: Develop fair market value (FMV) support for capital, service, and disposables—grounded in regulatory expectations.
• Discounts, Rebates & Bundled Pricing: Design programs that meet AKS discount safe harbor requirements and support customer reporting obligations.
• Evaluations & Pilot Programs: Structure compliant trials, loaned equipment, and early adoption pathways that convert without creating exposure.
• Audit, Remediation & Enforcement Readiness: Identify issues early, fix them cleanly, and prepare for DOJ and OIG scrutiny.
• Fundraising & Investor Readiness: Address FDA, AKS, HIPAA, and other regulatory diligence issues before they slow or kill deals.

Creating FDA regulatory and quality assurance schemes built for agility and pressure-tested against legal scrutiny.

• Regulatory Pathway Strategy (510(k), De Novo, PMA): Align FDA strategy with product, funding, and commercialization timelines.
• Claims, Labeling & Promotion: Define what you can say—and how to say it—across labeling, marketing, and investor communications.
• Pre-Clearance & Launch Readiness: Structure pre-market activities to avoid FDA enforcement risk while advancing commercialization.
• RUO/IUO, LDT & Diagnostic Positioning: Navigate complex diagnostic and research-use frameworks with clarity.
• Global Regulatory Alignment (EU IVDR, CE Marking): Coordinate U.S. FDA and EU IVDR strategies to ensure consistent positioning.
• Inspection & Enforcement Preparedness: Be ready for FDA audits, warning letters, and regulatory inquiries.

Designing practical data compliance strategies across various industries that require access, use, and storage of data.

• HIPAA Applicability & Structuring: Determine when you are a Covered Entity or Business Associate—and when you’re not – and guide you on your privacy and data security obligations.
• Healthcare Data Mapping & Risk Assessment: Align data flows with HIPAA, the FTC Health Breach Notification Rule, state, and international privacy laws (GDPR).
• GDPR, State Privacy Law & Cross-Border Data Strategy: Build GDPR- and US state-specific compliant frameworks for data, trials, and operations that cross state lines or span globally.
• BAAs & Vendor Ecosystems: Structure compliant relationships with providers, payors, cloud vendors, and partners.
• Patient-Facing Policies & Consents: Draft privacy notices and consents that reflect real-world product use and regulatory expectations.
• Incident Response & Data Risk Mitigation: Prepare for and respond to potential data breaches and regulatory exposure.

Delivering governance and ethics solutions designed to evolve with your business and pass stakeholder diligence at every critical phase.

• Board & Committee Governance: Build governance structures, committee charters, and oversight processes that support scaling companies in regulated industries.
  Code of Ethics & Business Conduct: Draft and implement codes of ethics, standards of conduct, and compliance expectations tailored to life sciences, MedTech, diagnostics, and digital health companies.
• Conflict of Interest & Disclosure Frameworks: Establish practical processes for conflicts, outside activities, gifts, entertainment, and related-party transactions.
• Whistleblower, Reporting & Non-Retaliation Programs: Design reporting channels, investigation protocols, and non-retaliation protections that support early issue spotting and defensible escalation.
• EEO/Employment Compliance Programs: Design policies and processes around employment decisions such as hiring, evaluations, disciplinary actions, incident response, and mass-terminations (layoffs, RIFs, position eliminations, etc.) that comply with federal and state EEO laws prohibiting discrimination, harassment, and retaliation.
• Policy Architecture & Governance Controls: Develop policy suites covering compliance oversight, approval workflows, delegations of authority, and internal accountability.
• Training, Certifications & Annual Attestations: Operationalize code of conduct training, annual certifications, and acknowledgment programs across employees, leadership, and third parties.
• Regulatory & Investor Readiness: Position your governance and ethics program to withstand board scrutiny, financing diligence, and regulator review.

Developing billing, reporting, and transparency processes that reduce exposure before problems arise.

• Sunshine Act / Open Payments Program Design: Create practical systems for identifying, tracking, valuing, and reporting transfers of value under the Physician Payments Sunshine Act and CMS Open Payments requirements.
• Spend Classification & Reportability Analysis: Assess consulting fees, meals, travel, education, research payments, evaluation units, and other transfers to determine what is reportable and how.
• Billing & Charge Capture Controls: Build controls around billing practices, pricing logic, discounts, rebates, credits, and documentation to support compliant reporting and defensible reimbursement practices.
• Field & Commercial Spend Monitoring: Align sales, marketing, medical affairs, and finance workflows so reportable spend is captured accurately and consistently.
• Dispute Resolution & Data Validation: Prepare for physician or teaching hospital disputes, data corrections, and annual submission review.
• Cross-Functional Reporting Infrastructure: Integrate legal, finance, commercial, and operations teams into a repeatable compliance process—not a year-end scramble.
• Audit & Enforcement Readiness: Identify gaps, remediate weak controls, and prepare for CMS, OIG, or internal audit scrutiny.

Structuring complex frameworks for global and multi-state companies with cross-border risk and consumer obligations.

• FCPA & Anti-Corruption Compliance: Build anti-bribery and anti-corruption programs covering distributors, consultants, healthcare professionals, international expansion, and third-party risk.
• Third-Party Due Diligence & Controls: Structure onboarding, contracting, payment controls, and monitoring for agents, channel partners, and foreign intermediaries.
• Books, Records & Internal Controls: Align documentation, approvals, and finance controls with FCPA and broader compliance expectations for accurate books and records.
• SEC Disclosure & Governance Risk Support: Advise on disclosure-sensitive compliance issues, governance controls, and diligence questions that arise in financing, growth, and strategic transactions.
• Consumer Fraud & Deceptive Practices Risk: Review marketing, product claims, website statements, and customer-facing practices for exposure under consumer protection laws, unfair competition laws, and deceptive trade practices statutes.
• Unlawful / Unfair Competition Compliance: Assess go-to-market conduct, comparative claims, channel behavior, and commercial practices for risk under unfair competition and false advertising frameworks.
• Investigations, Remediation & Response Planning: Help companies identify issues early, investigate efficiently, and implement corrective action before exposure compounds.

Partnering with your clinical, R&D, and executive teams to support innovation, operational discipline, and defensible oversight for critical development projects.

• Clinical Compliance Program Design: Build compliance frameworks for clinical development, investigator interactions, study operations, safety oversight, and research-related documentation.
• Human Subjects & Research Governance: Support research governance structures, consent-related workflows, sponsor and site controls, and operational policies that align with regulated clinical environments.
• Clinical Trial Contracting & Oversight: Structure agreements and internal processes involving sites, investigators, CROs, vendors, and research partners.
• Research Billing, Reimbursement & Spend Controls: Address compliance issues arising from research funding, study-related payments, grants, and operational spend.
• Animal Care and Use Program Development: Execute Animal Care and Use Programs, including governance structures, policies, training, oversight processes, and escalation pathways for preclinical and translational research environments.
• IACUC / Animal Research Oversight Support: Support institutional animal care and use oversight, protocol governance, vendor and facility controls, and compliance documentation.
• Inspection, Audit & Corrective Action Readiness: Prepare research and animal care programs for internal audits, sponsor diligence, and regulator or accreditor scrutiny.