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Hacked by Zeo_Kun 

contact me:zeo900k@gmail.com

 

We have substantial experience at all levels of the FDA and  many other federal, state, and local government agencies.  We interact with those agencies in every  manner including face-to-face, by phone, and by email.  We have prepared many product applications,  meeting packages, briefing letters, opinion requests, and other communications.  Here are some example project areas:

  • Interaction with the FDA and other Government Agencies at All Levels
  • Regulatory filings with Federal, State, and Local Agencies
  • Selection and Creation of Regulatory Approach and Position
  • Pre-IND (Pre-Investigational New Drug Application Meetings
  • IND’s (Investigational New Drug Applications)
  • Clinical Trial Protocol Development and Operations
  • NDA’s and 505(b)(2) NDA’s (New Drug Applications)
  • ANDA’s (Abbreviated New Drug Applications)
  • Device 510(k)’s
  • Device PMA’s (Premarket Applications)
  • Dietary Supplement structure and function claims letters and supporting research
  • Drug, Device, Cosmetic, and Dietary Supplement Labeling

 

Hacked by Zeo_Kun

contact me:zeo900k@gmail.com