General Contract Lab Testing:
Chemical Analysis Service
Analytical Testing contract lab
Assay Development
Assay Validation
Product Testing contract lab
Quality Control Testing
Chiral Separation
Stability Indicating Assays
Bioanalytical Contract Lab Service:
Assay Development
Method Validation
Automated Solid Phase Extraction
Automated Liquid-Liquid Extraction
Protein Analysis
LC/MS/MS, GC/MS/MS
Product Development and Reverse Engineering Services:
High Resolution Mass Spec
Accurate Mass
Impurity Identification
Impurity Profiling
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Microbiology Contract Lab Testing:
Pharmaceutical Microbiology contract lab
Medical Device Microbiology contract lab
Food Microbiology contract lab
Water Testing contract lab
Air Sampling and Testing
Bacteria Identification
Microbial Limit USP <61>
Sterility Testing USP <71>
LAL Endotoxin Testing
Bioburden Testing
Genetic Identification of Bacteria
RiboPriting
Contamination Study
Antimicrobial Effectiveness Testing USP <51>
Minimum Lethal Concentration
Bioburden Test
Total Aerobic Microbial Count
Mold, Yeast & Mold Testing
AET- Antimicrobial Effectiveness Testing USP <51> Or Preservative Effectiveness Testing
Minimum Inhibitory Concentration (MIC)
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Regulatory and Compliance Services
Outsource Regulatory Services
Preparing IND, NDA, ANDA, and CMC Documentation
Interaction with FDA for Regulatory Submissions
Providing Strategies for Successful Regulatory Submissions
Fast Track Submission
Phase I, Phase II, Phase III Regulatory Consulting
Providing Electronic Submission and Consulting
Audit Services
Laboratory Audit
Manufacturing Audit
Audit Report
Quality Assurance Audits
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Validation Services
Software Development
Software Validation (21CFR Part 11)
Validation Package
Software Testing
Equipment Validation
Laboratory Instrument Validation
Manufacturing Equipment Validation
Installation, Operational, and Performance Qualification and Verification
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