Medical, Legal and Regulatory

Clinical Development

  • Bench/Toxicology assessment & analysis
  • Clinical strategy & protocol development
  • Investigator recruitment
  • Patient recruitment
  • Contract budget negotiations
  • Project management & site monitoring
  • Orphan Drug market analysis & research


Regulatory

  • FDA Submissions: Rx , OTC , Bio-Generics
  • Dossier preparation
  • FDA /EU /CPSC / DEA representation
  • Project management
  • Medical due diligence



 

 

 

The Heart of It All

 

Medical, Legal and Regulatory expertise often mean the difference between success and failure.  Whether it be overspending for a clinical trial or mishandling key FDA relationships, our industry has too many examples of what not to do...needlessly.

 

Our experts know how to do it right, whether it be in the US or EU.  Visit with us and see how you can put our experts to work for you!