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