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Regulatory Affairs

We know how critical it is to assure a sound regulatory strategy, trial design, and regulatory communication from the concept stage of a clinical trial.

  Our team is comprised of regulatory professionals with many years of experience either working for or with the FDA.  
  CRI Regulatory Affairs Services:  
Site Audits  
Contract Research Organization Audits  
Standard Operating Procedure Development  
Regulatory submissions  
U.S. Food and Drug Administration contact  
Serious Adverse Event Reporting  
















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