In February 2026, the Food and Drug Administration (FDA) outlined a meaningful evolution in the Agency’s evidentiary approach to drug approval: establishing one adequate and well-controlled trial, supported by confirmatory evidence, as the default basis for marketing authorization. This position...
Expertise: Consulting 209 results
The Trial Master File (TMF) has long been a cornerstone of clinical research, serving as the primary record of study oversight, documentation integrity, and adherence to GCP standards. As modern programs grow in scale and complexity—often spanning multiple regions, partners,...
Consulting
Trusted Consulting from Bench to Market
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...
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