Program & Process Development
Efficient & Results-DrivenDriving Success across the drug development lifecycle
Your product is your manufacturing and testing process, by building your process / analytics early in the drug products lifecycle we ensure you get your product to your patients safely and efficiently.
Our focus is on getting results without wasting time or resources
Using our extensive experience in drug development and current industry technology and trends we ensure no wasted effort or experimentation resulting in fast, reliable, and efficient drug supply to meet your clinical and corporate milestones.
Cutting Out Excess & RisksA Phase-Appropriate CMC Approach
Fast tracking drug development and optimizing patient safety, production efficiency and supply reliability to accelerate market access.
Pre-Clinical:
Begin your development with the end state in mind, we develop a custom optimized manufacturing process for your candidate that meets your quality and supply model and supplies your non-clinical studies
Phase 1/2:
Building upon good development foundations to lay the groundwork for a robust and reliable clinical supply and commercial product launch.
Pre-Commercial Launch:
Ensure Process Control, Consistent Product Quality, and be submission ready
Post-Commercial Support:
Maintain Compliance and Expand Your Market
By hammering a phase-appropriate business model, we ensure programs are efficient, cost-effective, and designed for long-term success.
Rational Design, Reliable ResultsEmphasizing Process Design &
Product Quality
High Product Quality
Driven through rational, data-driven process design.
Timeline Acceleration
We perform only the core experiments necessary to achieve meaningful results.
Supply Reliability
Our process helps ensure robust supply and predictable performance.
Proven Technologies
We leverage established manufacturing platforms to minimize risk.
Supply Planning & Commercial ReadinessStrategic Planning for Reliable Supply
With experience in commercial processes, we guide program development toward outcomes that meet both patient and corporate needs efficiently.
Supply Modeling Driving Scalable Success
Vendor selection and facility design
Ensure sufficient clinical & commercial material
Connect With Our Team TodayAdvance Your Drug Program
with Confidence
Start building reliable, high-quality drug development programs today.