Chemistry, Manufacturing, and Controls CMC Documents

  • 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