Routine Testing
Services (GMP).
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Together with state-of-the-art lab equipment, our completely cGMP certified environment and proven scientific know-how deliver first-rate services and 100% compliance. You can rely on our routine testing services because we are a US-FDA inspected facility and a certified pharmaceutical establishment with a qualified person.
Clinical & Commercial
Batch Release
Clinical & Commercial
Batch Release
Testing of your commercial and clinical batches for the US and EU markets, including comprehensive qualitative and quantitative analysis.
QC
Analysis
QC
Analysis
Are you trying to find a trustworthy partner to help you with some of your regular testing, or are you dealing with missing capacities?
Stability Studies
Stability
Studies
Sample storage in climate chambers under regulated circumstances and stability testing carried out in accordance with predetermined test plans.
In-Vitro Bioequivalence (BE)
In-Vitro
Bioequivalence (BE)
Research and comparative evaluations adhering to USP <1090> and FDA guidelines are necessary to secure a biowaiver for your generic items.
Analytical Method Validation
& Transfer
Analytical Method Validation
& Transfer
GMP-compliant written procedures, approved protocols, validation or transfer reports, and other documentation for various methods.
QC Analysis
You can outsource several kinds of tests and different analytical procedures for your routine testing. You may effectively assign available capabilities to mission-critical jobs, handle workforce shortages, manage seasonal peaks, and minimise expenditures in expensive equipment that is not routinely utilised with our FDA-inspected and GMP certified laboratories.
- DISSOLUTION / IVRT: Manual or automated dissolution tests performed and protocolled according to your validated method by our GMP-certified laboratory.
- ASSAY, DEGRADATION PRODUCTS, AND CU: Content testing according to your validated method. Professional sample management, test execution, and documentation.
- ANALYTICAL METHODS: Use our capacities and expertise for performing routine analysis with your analytical method (LC, UV-Vis, IC, GC with head space).
- PHYSICAL TESTING: Outsource your physical tests such as capsule disintegration time, uniformity of mass, tablet breaking force (hardness), friability, dimensional measurements, or powder characterization.
- LC-MS TESTING FOR IMPURITIES / NITROSAMINES: Documented proof for the absence of carcinogenic impurities in your finished product with our LC-MS testing service.