A marketing application is judged on the strength of its scientific evidence. But regulators can only evaluate that evidence when it has been translated into a complete, technically compliant, internally consistent, and navigable application. That is why a complete dossier...
Expertise: Consulting 206 results
In clinical trials, the trial master file (TMF) is more than a collection of required documents. It is the evidence base that demonstrates how a study was planned, conducted, monitored, and overseen. As trials become more global, digital, and outsourced, that evidence...
The U.S. Food and Drug Administration’s (FDA) renewed focus on drug repurposing is bringing fresh attention to a regulatory pathway that has quietly shaped drug development for decades: 505(b)(2). Starting out as a critical mechanism bridging the gap between traditional 505(b)(1) new drug applications and abbreviated...
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Model-Informed Drug Development
Make better development decisions—earlier, faster, and with greater confidence Model-informed drug development uses modeling and simulation to predict how a drug may perform across doses, populations, and development scenarios. By applying the right quantitative approach at each stage, sponsors can...
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BIO International
Recent regulatory developments are reshaping how sponsors think about evidence, oversight, and operational readiness. In a New England Journal of Medicine Sounding Board, FDA leadership announced that one adequate and well-controlled clinical trial — supported by confirmatory evidence — could become the...
In our recent blog examining the FDA’s move toward a one pivotal trial approval pathway, we explored what this shift means for clinical strategy, regulatory engagement, and evidentiary rigor. As development programs concentrate approval decisions into a single adequate and well-controlled study, the implications extend well...
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...
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,...
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