STRATEGIC SOLUTIONS FOR MEDICAL PRODUCT SUCCESS.

SUPPORT FOR THE ENTIRE LIFECYCLE.

REGULATORY

REGULATORY STRATEGY

• Regulatory Roadmap
• FDA Special Programs and Expedited Pathways
• Preparation for FDA meetings
• Investor-Ready Presentations
REGULATORY AFFAIRS

• FDA Submissions
• Supplier and CMO Qualification
• Interim Staffing
• Regulatory Training

CLINICAL

CLINICAL STRATEGY

• Clinical Development Plan
• Real World Data/Evidence
• Adaptive Trials
• IND/IDE Preparation
CLINICAL TRIALS

• Clinical Trial Design
• DSMB Support
• Biostatistical Analysis
• Clinical Investigation Report

Quality & Compliance

Quality Systems

• SOP Development
• Process Improvement
• Supplier Management
• Remediation
INSPECTION READINESS

• GCP, GLP, GMP Mock Audits
• Inspection Readiness Training
• On-site and Remote Inspection Support
• FDA 483 and Warning Letter Response

MARKET ACCESS

FEDERAL MEDICINE

• Government Funding Support (Military, BARDA, etc.)
• Military Health System Access (DOD & VA)
REIMBURSEMENT

• Reimbursement Planning
• Coding and Coverage Analysis

OUR DIVERSE CLIENTELE.

We bring clients right-sized solutions. From start-ups to small and medium companies, to multinational corporations, the HIC client is as diverse as the medical product landscape.

We work across the medical device, diagnostic, pharmaceutical, biotech sectors to provide solution-driven strategies that lead to commercial success.