Barry Sugarman, is a former owner of a group of pharmaceutical, dietary supplement, device, and cosmetic manufacturing and distribution companies. Barry has over 30 years of experience at all levels with FDA regulated companies that are large, medium, and small. Barry is an expert in drug, device, biologic, combination product, dietary supplement, and cosmetic product development 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, President, Diverstech Co.
Phone (424)423-9559
FAX (310)454-9592
For an immediate response to a specific need, please email: barry@diverstech.com or call 1-424-423-9559