Drug Solution Development

  • Drug Solution and Delivery Development Expertise in the development of cGMP fill and finish operations for pre-filled syringes and auto-injector systems including the development of comprehensive Chemistry and Manufacturing Control (CMC) sections of a New Drug Application (NDA)
  • Experience in the identification and qualification of suppliers of device components and assemblies, drug solution excipients and active pharmaceutical ingredients (API)
  • Experience in working with container closure system manufacturers in the selection of drug contact materials least likely to affect the long term shelf life of a given drug product
  • Expertise in the design, conduct, and analysis of ICH compliant drug stability studies
  • Experience in the development of or transfer of assay methods and specifications for API, excipients, and final drug product solutions