View our comprehensive test services for pharmaceutical products.
| Service Categories | Drug Phase | Lab Sites |
|---|---|---|
| Analytical Research & Development (ARD) Method Development/Validation (MD/MV) • Assay & Related • Elemental Impurities • Residual Solvents • Extractables & Leachables • Identification of Impurities and Degradation Products • Investigations • Consulting for CMC, Reg. Affairs & Product Approval (RCA) | Initial Product Qualification Product Validation Clinical Studies pIND to Life Cycle Management (LCM) | North America Itasca, IL Europe Leuven, BE |
| Raw Material Testing (RMT) • Compendial Testing (USP/EP/JP) for Excipients • Method Feasibility and Verification • Container/Closure Testing, USP <381>,<660>,<661> | Initial Product Qualification Product Validation Clinical Studies QC Lot Release (Routine) | North America Itasca, IL SLC, UT Europe Leuven, BE |
| Stability Studies • API Stability • Drug Product Stability • In-Use Stability Studies • ICH Stability Storage at SLC 25C/60%RH, 30C/65%RH, 40C/75%RH and 2-8C • Photostability at Itasca | API and Drug Product Shelf-Life studies | North America Itasca, IL SLC, UT Europe Leuven, BE |
| Batch Release • API Release • Drug Product Release | QC Lot Release (Routine) | North America Itasca, IL SLC, UT Europe Leuven, BE Wiesbaden, DE |
| Microbial Testing + Sterility Assurance • Bacterial Endotoxins (LAL) Test • Bioburden • Microbial Identification • Environmental Monitoring (EM) • Container Closure Integrity Testing (CCIT) | QC Lot Release (Routine & Stability) | North America Itasca, IL SLC, UT Europe Leuven, BE Wiesbaden, DE |
| Sterility Assurance – USP/EP Closed Membrane Filtration • Parenteral Drug • Ophthalmic (eye drops, gels, ointments) • Pre-filled syringes & devices • Other pharma products | Initial Product Qualification Product Validation Clinical Studies QC Lot Release (Routine) | North America Itasca, IL SLC, UT Europe Wiesbaden, DE* |
| Sterility Assurance – USP/EP Direct Immersion • Combination drug/device products • Tissues & tissue-based products • Medical devices | Initial Product Qualification Product Validation Clinical Studies QC Lot Release (Routine) | North America Itasca, IL SLC, UT Europe Wiesbaden, DE* |
