In collaboration with other experienced regulatory professionals, I provide regulatory consultation and services to companies regulated by the US FDA, EMA, and similar agencies in other countries. Services include:
Expert assistance in addressing complex scientific issues, evaluating program design and results, interpreting data, preparing regulatory submissions, participating in regulatory meetings, or serving as a member on your advisory board.
Put together customized teams with the specific expertise needed to provide comprehensive analysis and actionable recommendations, conduct due diligence, evaluate product licensing opportunities, or manage regulatory submissions and interactions with the regulatory agencies.
Specialty Areas (CMC)
Provide strategic and tactical expertise in addressing your Chemistry, Manufacturing, and Controls (CMC) needs from early non-clinical investigations, through human clinical trials, up to commercialization, and post-approval maintenance.
Contact Daniela Drago, Ph.D.
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