CMC Regulatory
Develop your Chemistry Manufacturing, Controls and beyond Strategy and Roadmap
CMC experts initiate their work from early stages of development and become increasingly central and key functions as the product matures.
Our CMC experts know how to define your strategy and roadmap, find creative approaches to overcome challenges, and assist you with the required implementation.
| CMC | Early Stage | Pre-clinical | Clinical | Registration | Market |
|---|---|---|---|---|---|
| Define CMC strategy and roadmap |  | | |||
| Lead and support CMC gap assessments | | | | | |
| Lead and support: process development (&trouble shooting), process scale up, tech transfer, process risk assessments, comparability exercises, process characterization and process validation | | | | ||
| Contract Manufacturing Organization (CMO) selection and supervision including Person in Plant | | | |||
| Project management and coordination activities | | | | | |
| Writing and reviewing Module 3 for IND and IMPD submissions | | | |||
| Support with analytical method development and validation | | | |||
| Provide ongoing CMC support remotely and/or at client’s offices (including master and executed batch records review, etc.) | | | | ||
| Lead and support CMC inspection readiness and risk assessment processes | | |
