- We provide services for low-molecule pharmaceuticals and also biopharmaceuticals such as antibodies.
- We offer services of method development and validation to prepare filing.
- We perform various testing in a timely manner.
Eurofins Analytical Science Laboratories, Inc.
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Eurofins Analytical Science Laboratories, Inc. (E-ASL) utilizes the global network of Eurofins companies for GMP testing and provides solutions for various analytical testing in drug development processes from new drug development to commercial manufacturing.
Pharma / BioPharma Testing Services
Method Development & Quality Testing
Microbiological Testing
- We offer services of method development and validation for any dosage form.
- We support method transfer to any other laboratories.
Impurity Testing
- We offer services of Residual Solvents / Impurities (ICH-Q3C), and Trace Metals (ICH-Q3D) testing.
- We offer services of Extractables & Leachables testing (ICH-Q3E to be adopted).
- We offer nitrosamine testing (NDMA,NDEA, and NMBA etc.).
Formulation Development Support
We support formulation development by non-destructive analysis and imaging analysis.
Foreign Matter Analysis
We analyze foreign matters in tablets and insoluble matters in liquids.
Stability Testing
We offer stability testing under various conditions.
Reference Standards Management
We comprehensively support quality control, storage management, and shipment of reference standards. (Purchasing is negotiable.)
Biosafety Testing
We provide mycoplasma testing and viral clearance studies for biopharmaceuticals.
Others
- We provide testing services under quality system management in compliance
with Pharmacopoeia (JP, USP, EP). - We utilize the global network of Eurofins companies.