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