Clinical Research Management




Regulatory Support

 

Our highly qualified team provides services for regulatory support both in the provision of applications and reports to the FDA, together with providing review of clinical site essential documents on behalf of the Sponsor.

We offer the following Regulatory services:

  • FDA Regulatory Submissions including: 
    >IND >BLA
    >NDA >IDE
    >510 (k) >PMA

     
  • Review/Evaluation of Pre-Clinical Data
  • Support for FDA Meetings
  • Master File Maintenance
  • Review of Site’s Essential Documents

     

     




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