CLIA/CAP Clinical Lab for FDA Clinical Trial Bioanalysis
Project Description
USA CAP/CLIA Clinical Laboratory needed for bioanalysis for FDA Clinical Trial of new regulated medical product used to assist doctor in diagnosis and treatment. Transfer, development and validation of a LC/MS based urine biomarker assay as well as bioanalysis
Project Information
Number:19-01533
Industry:Pharmaceuticals
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Other pharmaceuticals laboratory services.
Other Pharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :
- Drug Discovery Testing
- Drug Development Testing
- Non-Clinical Study Testing
- Preclinical Study Testing
- Clinical Trials Testing
- Pharmacokinetics (PK) Testing
- Pharmacodynamics (PD) Testing
- ADME Testing
- Sterility Testing
- Pyrogens Testing
- Endotoxins Testing
- Raw Material Testing
- Finished Product Quality Control Release Testing
- Real-Time Stability Testing
- Accelerated Stability Testing
- Method Development Testing
- Method Validation Testing
- Drug Release/Dissolution Testing
- Extractable Testing
- Leachable Testing
- Elemental Impurities Testing
- Packaging Testing
- Child-Resistant Packaging Testing
- Container Closure Integrity Testing (CCIT) Testing
- High Throughput Screening Testing
- Reverse Pharmacology Testing
- Excipients Testing
- Active Pharmaceutical Ingredient API Testing
- Toxicology Testing
- Toxicity Testing
- Microbiology Testing
- Strength Testing
- Quality Testing
- Purity Testing
- Consistency Testing
- Acid Insolubles Testing
- Acid Solubles Testing
- Alkali Solubles Testing
- Alkalinity Testing
- Appearance Testing
- Boiling Point Testing
- Congealing Temperature Testing
- Flash Point Testing
- Melting Point Testing
- Freezing Point Testing
- Hardness Testing
- Heat of Combustion Testing
- Preservatives Testing
- Loss on Drying (under Vacuum) Testing
- Loss on Ignition Testing
- Melting Point Testing
- Mineral Analysis Testing
- Non-aqueous Titration Testing
- Normality Testing
- Organic Acids Testing
- Organic Extractives Testing
- Oxidizing Substances Testing
- Peroxide Value Testing
- Pour Point Testing
- Reactivity Testing
- Reactivity to Water Testing
- Reducing Substances Testing
- Refractive Index Testing
- Residue on Evaporation Testing
- Residue on Ignition Testing
- Saponification Value Testing
- Sieve Analysis Testing
- Silver Reducing Substances Testing
- Silicon Testing
- Sulfur Testing
- Sodium Testing
- Specific Gravity Testing
- Specific Rotation Testing
- Sugars Testing
- Sulfur Compounds Testing
- Surfactants Testing
- Talc Testing
- Titration Curve Testing
- Total Halides Testing
- Total Reducing Compounds Testing
- Unburned Carbon Testing
- Uncarbonized Constituents Testing
- Unsaponifiable Matter Testing
- UV Absorption Testing
- Volatile Matter Testing
- Volatile Suspended Solids Testing
- Weight Variation Testing
- Cytotoxicity Testing
- Elution Testing
- Agar Diffusion Testing
- Bioburden Testing
- Antimicrobial Effectiveness Testing
- Particulates Testing
- Total Combined Mold & Yeast (TYMC) Testing
- Total Aerobic Microbial Count (TAMC) Testing
- Testing
