Transfer, develop, optimize, and qualify / validate analytical test methods by exceptionally skilled analysts; full test method life cycle support.
Provide in-house analytical testing capabilities to support ongoing cGMP operations.
Perform USP and other compendial monograph tests.
On-site raw material testing and release.
On-site environmental monitoring and trending.
Conduct in-process material and final product release tests.
Develop and execute product storage and stability testing programs; analyze and trend stability data for expiry development and confirmation; qualify / validate stability-indicating test methods.
Reference material production, qualification, and maintenance.
Support process development/improvement and process validation projects (e.g., comparability and forced degradation study design and execution).
