SMART First Human Dose (FHD)

Efficiently transitioning a solid oral dose drug from candidate selection to first human dose clinical trials presents multiple challenges for sponsor companies and can take up to two years to prepare for your first clinical trial in the US. Leveraging the experience and expertise of an integrated global CDMO can enable a seamless solution and accelerate the delivery of treatment to patients in need.

PCI Pharma Services’ SMART FHD team includes experienced Clinical Supply Managers, Regulatory Scientists, Formulation Scientists, Packaging Technologists, Analytical Chemists, and Quality Assurance/QPs. Learn how finding a CDMO with the right team of experts can aid drug development preparation activities plus regulatory and clinical trial supply management, reducing timelines to first human dose clinical trials by months and accelerating the path to market.