Consulting
Trusted Consulting from Bench to Market
From early R&D through commercialization, our team delivers scientific and regulatory expertise.
Expertise: Consulting 223 results
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...
Consulting
eTMF Site and Country Quality Reviews
Thank you for downloading our “eTMF Site and Country Quality Reviews” guide. Download the PDF here.
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...
Consulting
Catherine Gatza, Ph.D.
Consulting
Seth DePuy, Ph.D.
Consulting