Expert design and execution of characterization studies for proteins, antibodies, biologics, and plasma-derived therapeutics, including binding kinetics, thermodynamic analysis, and structural characterization across SPR, ITC, DSC, AUC, CD, and DLS/MALS.
Full-cycle development, qualification, and validation of analytical methods for biologics, vaccines, and plasma products — from early-stage screening through phase-appropriate validation packages ready for regulatory submission.
CMC analytical strategy for IND, BLA, and MAA submissions, including data package review, regulatory authority response support, reference material design, and SOP development in partnership with QA.
Independent, vendor-neutral evaluation of biophysical and bioanalytical platforms for procurement, benchmarking, or capability audits — grounded in decades of hands-on deployment experience.
Strategic guidance for analytical development roadmaps, technical due diligence, and organizational capability building, including advisory board and expert witness engagements.
Customized training for scientific teams on instrumentation, assay design, data interpretation, and GxP principles — delivered on-site or remotely, calibrated to the audience.
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