SERVICES
Testing & Analysis
Microbiological Testing:
Ensure that proper testing is being conducted and consult on out of specification results, suitability, validation, verification. Suggest appropriate testing for time kill studies, preservative efficacy studies, cleaning and sanitizing studies for manufactures.
Chemical Analysis:
Guide on the appropriate chemistry testing requirements to meet label claims for OTC drugs, nutritional and dietary supplements. Method development, validations, verification or even method transfer protocols and reports along with the review process to meet the USP or ISO guidelines. Can provide guidance on raw material testing, out of specification, impurities such as residual solvents, pesticides, PFAS and heavy metals.
Stability Testing:
Guidance following the ICH guidelines for expiration dating or R&D stability programs for new formulations or package changes.