Design of in vitro ADME and PK studies, interpretation of data and integration of learnings into the overall program. We work with CROs to generate key data to fill a documentation gap or solve specific problems.
BCS has extensive experience moving drug development projects from discovery into regulated space. Key functions include oversight of analytical methods development for API characterization, stability program design, and GMP manufacturing.
Analytical methods are one of the most critical elements of any program; development, validation,
BCS has extensive experience moving drug development projects from discovery into regulated space. Key functions include oversight of analytical methods development for API characterization, stability program design, and GMP manufacturing.
Analytical methods are one of the most critical elements of any program; development, validation, and troubleshooting of rugged methods is a core strength. BCS is involved with a method from its genesis to support programs through Phase I.
Design pre-formulation and formulation experiments to enable various forms of administration and delivery in support of preclinical and clinical drug development stages.