HIC-Word Cloud

Catalyzing healthcare venture innovation by strategically engaging with the government

HIC_Word Cloud

our mission

We are world class experts in federal medicine who partner with promising life science ventures to develop and execute comprehensive strategies to work with the government, including advocacy and awareness programs for federal research or acquisition and securing U.S. and international regulatory approvals and certifications.

 who we are

  • interdisciplinary experts helping healthcare companies work with the federal government

  • Catalysts for medical innovation

  • Inspired to help life science entrepreneurs & ventures succeed

  • Committed to a "Culture of Quality" as a core principle

  • Cognizant that patients' lives are at stake

  • Passionate about fostering benefits for the public health

 what we do

  • ADVOCATE FOR THE MOST INNOVATIVE, IMPORTANT PRODUCTS TO THE FEDERAL GOVERNMENT

  • Establish key Public-Private Partnerships

  • Provide full-service interdisciplinary support across the lifecycle

  • Deliver high value-add services at attractive price-points

  • project-based pricing, not by the hour

  • Effective problem-solving using risk-based science

DEFINITIONS

pa·tient-cen·tric

adjective

Putting the patient first to respectfully and compassionately achieve the best experience and outcome for that person and their family.

cat·a·lyst

noun

A person or thing that increases the rate that precipitates an event.

in·no·va·tion

noun

A new method, idea, and/or product.

qual·i·ty

noun

The degree of excellence of something.

cul·ture

verb

Maintain in conditions suitable for growth.

our services 

 
SERVICES
federal medicine

Federal Medicine

Awareness campaigns, medical advocacy, establishing key government partnerships, procurement, tech-transfer, grant/contract research applications

quality

Quality

Establishing compliance with all applicable GMP/QS requirements, QA/QC support, SOP development, Verification, Validation, & Testing services

clinical advisory

Clinical Advisory

Develop clinical strategy, site selection, patient recruitment plans, write clinical protocols, provide clinical operations support, safety monitoring and reporting

biostatistics

Biostatistics

Develop Statistical Analysis Plans, complete power calculations, provide support for all FDA pre-submissions and marketing authorizations, including the collection and analysis of health economics data to support Market Access

Featured
regulatory

Regulatory

Lifecycle support for all devices, drugs, biologics, diagnostics, and combination products from pre-clinical, clinical, through post-marketing; including research filings and marketing authorizations

International certifications

International Certifications

Prepare submissions for review by Notified Bodies to obtain CE Mark and secure certification(s) to relevant internationally recognized consensus standards such as ISO 13485/14971, IEC 62304

Pre-Investment Federal Government Diligence

Pre-Investment Federal Government Diligence

Perform pre-investment due diligence relating to regulatory pathway viability, clinical trial design, quality capabilities, and potential interest from the federal government

post-approval support

Post-Approval Support

Perform mock audits at GCP/GMP sites, provide staff training, implement CAPAs, and respond to any potential compliance/enforcement actions

Contact Us

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our team

Industry, Government & Academia catalysts

Michael-Singer

michael singer

executive chairman

DEb Autor

Chief Executive Officer

Benjamin Eloff

Client Delivery, Quality & Satisfaction

Chris Priest Federal Medicine

CHRISTOPHER PRIEST

FEDERAL MEDICINE

Richard-W-Thomas

Tom THOMAS

federal medicine

Tom Colonna Headshot

Tom Colonna

regulatory

Victor Miranda Headshot

Victor Miranda

Medical Affairs

Joann Pfeiffer

JOANN PFEIFFER

CLINICAL & REGULATORY

Mathew Thomas

regulatory And Clinical

RENE-KOZLOFF

Rene Kozloff

Clinical advisory

RICHARD-CHIACCHIERINI

dick Chiacchierini

Biostatistics

Rick Thompson

Biostatistics

Nicholas Izzo

nicholas izzo

Pharmacology

Melissa Jeresano

POST-APPROVAL SUPPORT

Brit-Valdez-Nava

Brit Valdez Nava

Quality

Kathi Dastoli

clinical research coordination

testimonials

What our clients are saying

TESTIMONIALS

"We had followed an FDA regulatory strategy based on a consultants’ advice, although it was quickly determined that the prescribed pathway was not feasible for FDA approval or reimbursement coverage. We were subsequently able to swiftly modify the project course per H.I.C's recommendations and are now on track to receive FDA approval much quicker, with coverage for an even larger market, all with less regulatory risks.”

Joseph Sokol
CEO, iCardio.ai