Formulation Development

Our drug product formulation development experts are passionate about problem-solving and helping customers find the right formulation strategy to advance their products efficiently without sacrificing quality. As we work through this critical phase of your drug’s formulation, we draw on proven skills and a unique approach:

Capabilities

We have the technology and expertise to handle a broad range of complex oral solid dosage forms, topicals and oral liquids. We handle pediatric dosages, DEA controlled substances (schedule I to IV) and complex modified-release formulations, pellets and micro-dose tablets.

Process

Our formulation scientists and analytical chemists will work with you to design and execute all excipient interaction, pre-formulation, formulation, Design of Experiment (DoE) and Quality by Design (QbD) studies to ensure your product meets your clinical objectives and milestones. We aim to accelerate the process of bringing your projects to registration by efficiently and successfully identifying a lead formulation.

Scale-Up and Technology Transfer

We can provide small-scale proof-of-concept prototype batches, manufacture clinical trial materials, perform scale-up manufacturing and registration batch manufacturing and conduct technology transfer and validation services in preparation for commercial manufacturing.

Project Management

A dedicated project manager will oversee your project’s activities and progress, serving as your primary point of contact from beginning to end.