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Microbiology Consulting

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

Consulting Services
Chemical Analysis Service Analytical Testing contract lab Assay Development Assay Validation Product Testing contract lab Quality Control Testing Chiral Separation Stability Indicating Assays

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

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

Bioanalytical Consulting

Assay Development Method Validation Automated Solid Phase Extraction Automated Liquid-Liquid Extraction Protein Analysis LC/MS/MS, GC/MS/MS

Audit Services:

Laboratory Audit Manufacturing Audit Audit Report Quality Assurance Audits