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
