CMC Consulting Services

  • Expert Testimony/Patent Infringement
  • Manufacturing Route Selection
  • Potent Compounds
  • Process Validation
  • Supply Chain/CMO Management
  • Work Orders/MSAs/Terms and Conditions
  • Small Molecules
  • Antibody Drug Conjugates/Oncology and all types of Drug Development
  • Project Management
  • Quality Assurance/Manufacturing Batch Records
  • Due Diligence CMC Review Support
  • Regulatory Compliance
  • Clinical Trial Support Strategies
  • Formulation Development
  • Analytical Controls
  • Genotoxic Impurity Control
  • FDA Type C Meeting Support/Pre-meeting Packages
  • IND, NDA, BLA, DMF Content
CMC drug development services