Regulatory and Clinical Consultation Solutions Covering the Full Product Lifecycle
Service Offerings
Product Stage - 01
Business Case
- Due Diligence for Minority Investment or Acquisition
- Clinical Organization Structure and Design
- Adapt Clinical Policies and Procedures to New Regulatory Standards
- Presubmission Planning
- Negotiation with Regulatory Agencies
Product Stage - 02
Feasibility & Design
- Optimize Promotional Claims
- Labeling Strategy
- Literature Search
- Risk Management Plan
- Post-Market Performance Plan (IVD)
- Post-Market Surveillance Strategy (medical device)
- Publication or Evidence Strategy
- Benefit/Risk Assessment
Product Stage - 03
Design Verification
- Clinical Protocol Design
- Statistical Analysis Plan
- Data Management Plan
- Risk-Based Monitoring Plan
- Audit Plan
- Site Selection
- Vendor Selection
- Feasibility Clinical Trial (as applicable)
Product Stage - 04
Clinical Validation
- Clinical Trial Execution
- Leading Indicator Trial Health Metrics
- Risk Mitigation
- Final Study Report
- Regulatory Inspection Preparation
- Address Regulatory Body Questions
Product Stage - 05
Commercial Release
- Post-Market Performance or Surveillance Plan
- Abstract and Podium Presentations
- Peer-reviewed Publications
Product Stage - 06
Sustainment
- Post-Market Performance or Surveillance Reports
- Publications
- Update to Benefit/Risk Assessment