
Before you’re ready to have your drug evaluated by regulatory bodies, there are several steps that should be taken to ensure it will pass. Through everything from shelf-life studies to drug impurity identification, we’ll run the tests that allow you to identify areas for improvement.
- cGMP fill and finish operations for pre-filled syringes and auto-injector systems
- Chemistry and Manufacturing Control (CMC) sections of a Drug Application
- Identification and qualification of suppliers of device components and assemblies
- Drug solution excipients and active pharmaceutical ingredients (API)
- Formulation development
- Container closure system manufacturers in the selection of drug contact materials
- ICH shelf-life studies
- Assay method and specifications for API, excipients and final drug product
- Identification of drug impurities
- Toxicology studies per FDA Guidelines
Our primary expertise lies in the processes outlined above, but if you’re interested in other aspects of Device Developmental Activities, we’re happy to assess our compatibility with your needs.
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