Chemical Analysis Service:Analytical & Chemical Testing lab:
Assay Development
Assay Validation
Product Testing
Quality Control Testing
Chiral Separation
Stability Indicating Assays
Bioanalytical Laboratory 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
De-formulation
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Microbiology laboratory::
Pharmaceutical Microbiology Laboratory
Medical Device Microbiology Laboratory
Food Microbiology Laboratory
Water Testing and Water Microbiology Laboratory
Air Sampling and Testing
Bacteria Identification
Microbial Limit USP <61>
Sterility Testing USP <71>
LAL Endotoxin Testing
Bioburden Testing
Genetic Identification of Bacteria
RiboPrinting
Contamination Study
Antimicrobial Effectiveness Testing USP <51>
Minimum Lethal Concentration
Bioburden Test
Fungal, Yeast, & Mold Identification
Total Aerobic Microbial Count
AET- Antimicrobial Effectiveness Testing USP <51>
Or Preservative Effectiveness Testing
Minimum Inhibitory Concentration (MIC)
Microbiology Studies
Microbiology Analysis
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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
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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