Formulation support from Preclinical to Approval
CMIC assists clients in developing formulations and new dosage forms, building on the plan initiated in the drug discovery phase. With highly experienced pharmaceutical scientists and engineers, we offer streamlined formulation design, pharmaceutical process development (scale-up and optimization) design, manufacturing process design and specifications for packaging clinical trial materials. We provide comprehensive services, from preformulation to Investigational Medical Product (IMP) manufacturing and contract analytical testing (e.g., stability testing and pharmacokinetic testing, preliminary drug formulation study, analytical method development and validation [pre-clinical], and specification development). When researching your pharmaceutical candidate, we consider interaction with excipients, as well as how to efficiently develop the formulation process. Our expertise will move you quickly through the phases while maximizing your chance for success.
Our Edge in Formulation, Process and Analytical Development
Development Support
- Our advanced technology and extensive experience help clients increase efficiency of pharmaceutical development.
- We offer a broad spectrum of services ranging from preformulation and design of a new drug to modification of an existing drug
- Support for robust manufacturing processes (e.g. reviewing manufacturing conditions. Conducting manufacturing scale up and registration batches).
Services
Development:
- Preformulation (e.g., evaluation of physicochemical properties, stability profiles and degradation, etc.)
- Formulation design
- Process development (scale-up and optimization)
- Clinical trial drug product manufacture
- Technology expertise and validation for commercial manufacturing
Analytical:
- Analytical testing support of development work for selection of optimized formulation
- Analytical methods transfer
- Analytical method development and validation
- Cleaning verification method development and validation
- IMP Quality testing
