Chemistry, Manufacturing, and Control (CMC)
Any company involved in, or with the intention to perform, clinical studies must have access to top senior level CMC expertise.
CMC expertise is not only restricted to synthetic substances (NCE's), it is of equal importance for therapies based on biologics, cells and/or genes. A proper CMC strategy from late nonclinical (pre-clinical) development is essential for timely, cost effective and successful clinical studies and New Drug Application (NDA) registration.
- Manufacturing strategies, selection and evaluations
- Formulation and control methods strategies and evaluation
- Adopted development and drug supply strategies
- Expert advice on:
- Control methods development and validation
- Specifications for synthetic, biologics and cell therapy
- Formulation strategies and development
- Stability studies design and evaluation incl. statistical forecasting
- Selection of CDMOs and CMOs
- CMC due diligence
- Regulatory files DS and DP – reviews