Bernstein CMC Regulatory Consulting provides comprehensive regulatory compliance and pharmaceutical sciences development services to the pharmaceutical and biotech industry. We provide a full range of coordinated regulatory and technical services including conceptualization, definition and implementation of CMC development programs incorporating strategic planning and integration of CMC development plans with toxicology and clinical development requirements. We also prepare and/or review regulatory submissions (IND, NDA, CTA), conduct GXP compliance audits and manage and provide liaison with CMC contractors as a member of your project team.

David Bernstein is the principal consultant at Bernstein CMC Regulatory Consulting. He holds a BS in Pharmacy from Columbia University and MS and PhD in Pharmaceutical Sciences from the University of Michigan. He has over 30 years of hands-on industrial and CMC regulatory consulting experience. He has authored over 160 CMC sections of IND, NDA, CTA submissions and has represented numerous pharmaceutical and biotech firms at FDA.