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REGULATORY EXPERTISE FOR SEAMLESS SUBMISSIONS
 

bullet Regulatory strategy development
 
bullet Submissions project planning
 
bullet Clinical study protocol development
 
bullet Case Report Form development
 
bullet Monitoring plan review
 
bullet CRA / Monitoring services  including:
 
bullet Routine monitoring for post-market approval registry for cardiac re-synchronization device indicated for heart-failure.
 
bullet Routine monitoring for pre-approval study for cardiac re-synchronization device
 
bullet Routine monitoring for pre-approval study for deep brain stimulation device.
 
bullet Routine monitoring for pre-approval study for spinal technology.

 

 

 

 

 

 

 

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Last modified: February 07, 2011