Regulatory Affairs

Direction and expertise to gain approval in target markets

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Proactive risk identification

Optimized development planning

Experience across global health systems

Whether you are seeking a full-source solution, from strategy development through authorization, or discrete projects related to preparing your in vitro diagnostic for marketing approval, we are ready to help.


  • Clinical evaluation reports (CERs)
  • Opinion letters
  • Strategy documents
  • Agency responses
  • Audit preparation & support
  • AI
  • 483s
  • Warning letters
  • Biological safety evaluation


  • Regulatory strategy planning
  • Claims and labeling
  • Portfolio management
  • Project management
  • Agency meeting support
  • Post-market clinical follow-up plan support
  • Design control support
  • Risk management support
  • Regulatory compliance consulting
  • Registration and licensing support


  • 510k
  • De novo
  • CLIA waiver
  • PMA
  • IDE
  • Q-sub
  • CE support: tech file/design dossier

Because commercialization considerations are integrated into the plan, data endpoints can be designed to provide the edge you need in your product’s target therapy areas.

Your program will be designed to comply with all regulations governing quality systems, such as the U.S. Food and Drug Administration’s Quality System Regulation, ISO 13485 and ISO 90001. We take a proactive approach to avoiding regulatory sanctions associated with costly delays and limited market access.

Ready to Start a Conversation?

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