Randall Lis, Ph.D.
Chemistry Development and Regulatory Affairs Consultant
Dr. Lis serves as our CMC consultant with industry experience in the development of new drugs and therapeutic agents. He is responsible for setting the long-term strategy and vision for the regulatory function by providing global CMC regulatory management. He has filed over one hundred IND’s, NDA’s and other market product applications.
- Provides critical review of documentation supporting regulatory applications,
- Provides status of global regulatory affairs strategies and tactics, procedures and practices,
- Articulates complex regulatory CMC issues supporting global development and commercialization of early and late state products.
Dr. Lis received a B.A. in Chemistry from Rutgers University in New Brunswick, NJ and a Ph.D. in Organic Chemistry from Indiana University in Bloomington, Indiana.
- Regulatory CMC Strategy
- Small Molecules
- Technical Writing
- Global Submissions
- eCTD Formatting
- Program Management
- Scientific Knowledge Depth
- Quality Risk Management
- Regulatory Starting Material