Contract Laboratories: Chemical Analysis Service:Analytical & Chemical Testing
Method Development
Method Validation
Product Testing
Quality Control Testing
Chiral Separation
Stability Indicating Assays
Chemical Testing
Bioanalytical Contract Laboratory Service:
Bioanalytical Method Development
Bioanalytical 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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Contract Microbiology Lab Testing:
Pharmaceutical Microbiology
Medical Devices Microbiology
Medical Devices Method Development
Medical Devices Method Validation
Food Microbiology
Microbiology Method Development
Microbiology Method Validation
Water Testing
Air Sampling and Testing
Microbial 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
Fungal, Yeast, & Mold Identification
Total Aerobic Microbial Count
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 CMCs Documentation
Interaction with FDA for Regulatory Submissions
Providing Strategies for Successful Regulatory Submissions
Fast Track Submission
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
Facility Design and Validation
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