Aptar Pharma can assist you to select and test primary packaging components, containers and systems as well as drug delivery devices.
Our expert and experienced teams help customers mitigate the risks associated with container, primary package and drug delivery device selection while supporting product development moving forward.
Analytical Development Labs:
- US FDA-registered
- Analytical method development for the characterization of extractables and leachables
- Extractable and toxicology characterization packages ready for submission to the US FDA and other regulatory bodies
- Spray patterns and droplet size distribution characterization
- Force characterization measurement
- Mechanical and stress constraint testing
- Tomography used as a non-destructive tool to evaluate packaging systems, drug delivery devices and final drug products
Our sister-company Next Breath based in the US is a cGMP contract services organization specialized in OINDPs ; they offer:
- Pre-clinical formulation development to analytical testing in support of submissions to regulatory agencies
- Consulting and full support
- DEA License