Barry Sugarman, B.S.ENGR., is a former owner of a group of pharmaceutical, dietary supplement, device and cosmetic companies including manufacturing, distribution, and representation companies. Barry has over 36 years or experience in all aspects of FDA regulated companies and products including public and private, large and small firms at all levels. Barry is an expert at interactions with federal, state, and local government agencies, and in drug, device, dietary supplement, and cosmetic product development, marketing, and regulatory affairs.

 

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

 

Barry Sugarman, B.S.ENGR., President, Diverstech Co.

Phone (310)355-6046

FAX (310)454-9592

For an immediate response to a specific need, please email: barry@diverstech.com or call 1-310-355-6046