STRATEGIC SOLUTIONS FOR MEDICAL PRODUCT SUCCESS
SUPPORT FOR THE ENTIRE LIFECYCLE
Regulatory
HIC specializes in FDA regulatory strategy, submissions, and compliance, ensuring successful navigation of complex approval pathways for pharmaceuticals, biotech, medical devices, diagnostics, and digital health.
REGULATORY STRATEGY
Regulatory Roadmaps
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
HIC optimizes clinical trial design, biostatistics, and real-world evidence strategies to ensure regulatory compliance, data reliability, and efficient study execution.
CLINICAL STRATEGY
Clinical Development Plans
Real World Data/Evidence
Adaptive Trials
IND/IDE Preparation
CLINICAL TRIALS
Clinical Trial Design
DSMB Support
Biostatistical Analysis
Clinical Investigation Reports
Quality & Compliance
HIC ensures regulatory compliance through quality system development, GMP/GCP audit readiness, risk assessments, and remediation of 483s and Warning Letters.
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
483 and Warning Letter Response
Market Access
HIC drives market access through reimbursement strategy, coding analysis, and Military Health System and VA entry support.
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.
