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Related Small Molecules Services
The pharmaceutical industry is focusing on accelerating all aspects of drug discovery and development. This focus makes it critical to reduce the timeline from the initial idea to first-in-human (FIH) clinical safety and efficacy data for proof of concept. Aligning with a single service partner can reduce timelines, complexities, risks and costs associated with reaching FIH milestones.
Bioavailability hurdles, which are often a challenge in advancing new molecules and require enabling technologies even for phase I studies, must be factored into the choice of development partners. Another factor that can further accelerate your pathway is phase-appropriate processing for API, particle engineering and specialized finished drug products.
We can help you address these challenges and simplify the pathway to FIH verification.
Access the flexibility required to fit your molecule and drug program:
SimpliFiH® Solutions center on a rapid technology selection methodology that requires a single gram of API to identify a phase I appropriate approach.
The Lonza team works in an open and collaborative way, with good understanding of client requirements, from forecasting and project planning to delivery.
Stephan Bulat, Head CMC, Grünenthal
Our first-in-human SimpliFiH® Solutions package is designed to meet the needs of the vast majority of phase I programs, and provides integrated drug substance and drug product solutions in 32 weeks, incorporating:
Options for program customization regulatory services can include: