Discover how early CMC, process optimization, and formulation strategy drive scalable, commercially viable drugs.

Early-stage regulatory strategy is becoming a powerful driver of speed, risk reduction, and commercial value in drug ...

Predictive AI modeling startup and biotech-focused venture fund unite to accelerate next-generation therapeutics and reshape the FDA regulatory path. Together with QNova, we’re using AI to help ...

Client programs using CHOMax follow platform-defined workflows and phase-appropriate practices across the development lifecycle.

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Safety and efficacy of two candidates are currently being assessed in investigator-initiated clinical trials. BRC is planning to commence enrollment for Phase 2 and 3 trials by mid 2026. MONTEREY, ...