Characterize the material.
Understand physicochemical properties and drug–excipient compatibility. Define the target product profile and critical quality attributes.
INFORMSCharacterization findings and formulation considerations
Build understanding. Inform the next decision.
Scientific questions shape the work. Product attributes and experimental evidence guide the development approach.
A QbD-DRIVEN DEVELOPMENT APPROACH
Decisions grounded in product understanding.
Engage for an individual service or connect disciplines around a broader development program.
Evaluate the possibilities.
Develop proof-of-concept batches, evaluate lead formulations and examine packaging compatibility. Apply design of experiments where appropriate.
INFORMSFormulation assessment and selection rationale
Understand the process.
Map unit operations, equipment requirements and parameters that influence product quality and reproducibility.
INFORMSProcess understanding and control considerations
Build the evidence.
Evaluate scale-up considerations, control strategies and stability to inform the next development decision.
INFORMSStability findings and scale-up assessment
Start where your program needs us.
The pathway is a framework rather than a requirement to commission every stage. Discuss a specific analytical question, a formulation problem or a connected development scope.
Define success together.
Align the product objective, available evidence, technical dependencies, quality requirements and deliverables before agreeing the work.
A TECHNICAL CONVERSATION STARTS HERETell us what your
Tell us what your
product needs to do.
Share your product, scientific challenge and next milestone. Request an NDA before providing proprietary details.