Our Experts

Meet Our Team
of Experts

Get to know the dedicated professionals whose expertise
and insight drive every client’s success.

HIC Leadership

Our Team

With more than 150 consultants and a network in which approximately half are former FDA leaders, investigators, and subject-matter experts, our team brings an uncommon level of depth and precision to every engagement.

We draw from seasoned professionals spanning FDA, global regulatory bodies, industry, military health, and academia, giving clients access to the broad, multidisciplinary insight needed to navigate today’s complex regulatory and quality landscape.

For each project, we assemble a bespoke team tailored to the product, technology, and stage of development. This model ensures that clients work directly with specialists who have firsthand experience in regulatory submissions, GxP compliance, clinical development, and quality systems, backed by more than 850 combined years of FDA and global regulatory expertise.

Clients trust us because our advisors move quickly, analyze challenges with precision, and deliver practical solutions shaped by real operational knowledge. The result is guidance that is not only expert, but also strategic, actionable, and aligned with the realities of fast-moving biopharma, medtech, and digital health innovation.

Our Clients Have Included

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Pharmaceutical

Fortune 500 and global life sciences companies seeking expert support for regulatory strategy, submissions, and compliance

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Biotech

Emerging biotech and pharmaceutical companies advancing first in class and breakthrough therapies

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Medical Device

Top tier medical device and diagnostics manufacturers refining quality systems and preparing for inspections

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Digital Health

Digital health and software as a medical device innovators navigating evolving regulatory expectations and advancing pivotal studies

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eClinical & RWD/RWE Vendors

Real world data and eClinical technology companies aligning products, systems, and processes with FDA standards

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Academic Spinouts

Academic and research institution spinouts transitioning novel technologies toward commercialization

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Clinical Networks

Clinical research networks strengthening inspection readiness, site operations, and agency engagement

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Venture Growth

Venture funded companies, investors, and accelerators requiring specialized diligence and development insight

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CRO Partnerships

CROs and consultancies partnering with us for targeted FDA, quality, and clinical expertise

Our Expertise

Quality & Compliance

Representative Titles Held

  • FDA District Director
  • Senior Medical Officer, Office of Scientific Investigations (FDA/CDER)
  • Global Head of Quality (Top 20 Pharma)
  • Lead Auditor, ISO 13485 & MDSAP
  • Senior Director, Quality and Regulatory Compliance (Medtech Company)

Representative Experience

  • Managed FDA inspection readiness and remediation for 483s, warning letters, and consent decrees
  • Designed and implemented global QMS systems compliant with QSR/QMSR, ISO 13485, and MDSAP
  • Conducted over 800 GMP, GCP, and GLP audits globally, including contract manufacturers and CROs
  • Developed internal audit and training programs to improve CAPA execution and regulatory outcomes
  • Provided expert consultation for quality remediation during product recalls and FDA enforcement actions
  • Led preparations for FDA regulatory meetings

Representative Titles Held

  • Division Director, Office of New Drugs (FDA/CDER)
  • Director, Division of Therapeutic Biologics (FDA/CBER)
  • Deputy Director, Division of Epidemiology (FDA/CDRH)
  • VP, Global Regulatory Affairs (Top 10 Pharma)
  • Head of Regulatory Affairs, Global Device Manufacturer

Representative Experience

  • Compiled IND, NDA, ANDA, BLA, IDE, 510(k), De Novo, and PMA submissions
  • Developed regulatory pathways for combination products, orphan drugs, and 505(b)(2) submissions
  • Led briefing package preparation and regulatory engagement strategies for pre-IND, Type B/C/D, and Pre-Sub meetings
  • Advised investors and sponsors on FDA expectations, strategies, timelines, and milestones
  • Developed CMC packages for nanotherapeutics

Representative Titles Held

  • Clinical Team Leader and Division Director, Office of New Drugs (FDA/CDER)
  • Director, Division of Biometric Sciences (FDA/CDRH)
  • NIH-Funded Principal Investigator, Phase III Multisite Trials
  • Director, Clinical Safety Office (NIAID/NIH)
  • Senior Medical Officer, Good Clinical Practice Assessment Branch (FDA/CDER)

Representative Experience

  • Designed and managed adaptive, Bayesian, and RWE-integrated clinical trials across multiple therapeutic areas
  • Directed Phase I–III studies for CNS, oncology, infectious disease, and rare disease indications
  • Developed regulatory-aligned endpoints, estimands, and statistical analysis plans
  • Led IND development for novel agents with Breakthrough Therapy Designation and accelerated review
  • Conducted due diligence and strategic planning for clinical programs in M&A and portfolio expansion

Representative Titles Held

  • VP, Market Access and Reimbursement
  • Director, Coding and Coverage Strategy
  • Chief Acquisition Officer, Veterans Health Administration
  • Director, Defense Health Agency Pharmacy Operations
  • Major General, U.S. Army

Representative Experience

  • Secured national and local coverage, HCPCS codes, and formulary placement for novel therapeutics and devices
  • Developed value-based evidence strategies for diagnostics, AI/ML-enabled tools, and remote monitoring solutions
  • Supported successful product launches into VA and DoD through strategic procurement and federal contract alignment
  • Led engagement with CMS and commercial payors for breakthrough and first-in-class technologies
  • Aligned clinical data with reimbursement expectations to optimize coding, payment, and adoption

Contact Us Today

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