Areas of Expertise
Comprehensive Strategy
Regulatory – Quality – Clinical – Security – Commercial
Research & Background
SITREP
Comprehensive Gap Assessment
Due Diligence Activities and Intelligence Gathering:
Scientific, Technical, Commercial, Investment
Create and Implement Strategy
Implementing a quality system
Creating Regulatory Strategies
Drafting or Reviewing Clinical Protocols
Designing Successful Commercial Strategies
Biomarker Development
Translational Clinical Biomarker Support
RUO, IUO, IVD, SaMD, AI
Concept through Commercial Assay
Apply Design Controls
(US-FDA/IVDR Compliance)
Security and Intelligence
Security and Intelligence: important and over-looked industry segments.
Ensure supply, patient safety, transportation and protection globally.
From digital back-end, AI, to front-line tactical support:
Investigate, Protect, Enforce – PMA.
Extension of your TEAM
Consultant or Contract Management
Partner Outsourcing
RFP Qualification Process
Biospecimen Sourcing
Project Management Oversight
Marketing Strategy and Positioning
Field Reconnaisance
Executive Protection
Patient Accessibility and Safety
Securing & Infiltrating Medical Supplies
Starting with an Empty Slate?