CMC Consulting
- Write, review, and publish Chemistry, Manufacturing, and Controls CMC Documents
- Review Chemistry, Manufacturing, and Controls CMC Documents, including protocols and reports, for scientific merit and regulatory compliance
- Chemistry, Manufacturing, and Controls expertise for all stages of development for biologics, biosimilars, and biological/device combination products
- Chemistry, Manufacturing, and Controls CMC Documents gap analysis
- Assessment and evaluation of stability protocols and data
- Analytical method development