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Technical Services
Analytical Method Development/Validation
• Development and
validation of analytical methods in support of stability testing of drug
substance and drug product, residual solvent testing and cleaning validation
testing.
Raw Material/Excipient Testing
• Testing performed
according to the following compendia: USP, EP, BP, JP, ACS, or FCC, or performed
according to client supplied of vendor supplied methods.
Stability Testing and Stability Storage
• Testing performed to
support national and international regulatory submissions for new products.
Commercial product stability programs also supported.
• Stability storage
capabilities with a broad range of storage conditions including all ICH
conditions for long-term or accelerated stability studies as well as
photostability studies.
Comparative Product Testing
• Development and
validation of assay, impurity and dissolution methods for over-encapsulated
and/or de-branded market product.
• Testing performed to
support clinical release, clinical re-assay and stability programs.
Marketed Product Release Testing
• QA/QC release testing
performed to support marketed products.
Commercial Product Retain Program
• Services Provided to
store and inspect commercial product retain programs.
Consulting Services
• Consulting services
provided to support the writing of method transfer protocols, stability study
protocols, and analytical method validation protocols.
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