Trusted Consulting from Bench to Market
From early R&D through commercialization, our team delivers scientific and regulatory expertise.
From early R&D through commercialization, our team delivers scientific and regulatory expertise.
Antibody-drug conjugates (ADCs) represent one of the most dynamic areas of oncology drug development. By combining monoclonal antibodies, cytotoxic payloads, and chemical linkers, these therapies are designed to selectively target tumor cells while limiting systemic exposure. Each component contributes to...
As drug development becomes increasingly complex, Model-Informed Drug Development (MIDD) has emerged as a critical strategy for optimizing clinical trial design, enhancing regulatory engagement, and accelerating development timelines. While population pharmacokinetic/pharmacodynamic (PopPK/PD) modeling is a central component of MIDD, sponsors...
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In vitro / in vivo correlation (IVIVC) is a scientific approach used to establish predictive relationships between laboratory-based drug release profiles (in vitro) and pharmacokinetic behavior in humans (in vivo). By linking dissolution data with plasma concentration profiles, IVIVC helps...