Optimized Regulatory Solutions, LLC

Optimized Regulatory Solutions, LLC partners with customers to:

  • Provide innovative solutions to maneuver in this ever changing regulatory environment
  • Develop strategies together to commercialize as fast as possible
  • Analyze global RA footprint to optimize processes to facilitate faster submissions

Service Offerings:

  • Regulatory Strategy Development
  • Go to Market Strategies and Implementation
  • Submission Development and Review (includes but not limited to 510(k), PMA, IDE, presubmission packages and meetings)
  • Global Health Authority Strategies and Meeting Preparation
  • Regulatory Footprint Assessment 
  • Quality, Regulatory, Compliance Interim Leadership 
  • Team Development
  • Optimizing Processes and Increasing Team Throughput 
  • Excellence Center Development
  • Merger and Acquisition Integration
  • Due Diligence Support
  • Commercialization Pathways
  • Advertising and Promotion Reviews
  • Regulatory Assessment of Changes
  • Global Regulatory Affairs Compliance
  • Audit Preparation and Defense
  • Quality System Integration
  • Post Market Surveillance Support
  • Product Recall Support 
  • Consent Decree Mitigation