Formulations are developed based on extensive API characterization and pre-formulation assessments inclusive of robust problem statement analysis. Our science and engineering core strengths have enabled the development of technology selection methodologies and specialized lab-scale equipment that can accelerate proof of concept and early formulation studies while minimizing API requirements.
Our product development teams are equipped to meet all of your formulation and product development needs in a phase-appropriate manner, including:
- API characterization and problem statement definition
- Technology selection for best formulation options
- Addressing bioavailability or dissolution rate issues
- Profiling and modulating pharmacokinetics
- Developing a formulation strategy and requirements
- Developing and manufacturing phase-appropriate clinical material
- Developing and validating processing and analytical methods
- Regulatory preparation services including generating and documenting all required data for clinical trial filings.