Microbiology - Keyport, NJ - Loricon Testing

Loricon Testing Service, Inc. is one of the oldest, largest, and most experienced cGMP industrial microbiological facilities in the Eastern United States. With more than forty five (45) years of experience in microbiological testing of raw material, intermediary components, bulk, and finished products for the Pharmaceutical, Cosmetic, and Personal Care industries, Loricon holds a proven record of excellence. All testing conforms to cGMP, cGLP, FDA Bam, Direct USP Monographs, Cosmetic Testing and Fragrance (CTFA), and Clients’ Standards.

Microbial Limits Testing, USP, BP, EP, JP, CTFA, Clients Standards
Antimicrobial Effectiveness Testing, USP, BP, CTFA, Clients Standards
Growth Promotion Testing - USP
Microbial Identification (API, Crystal)
Time Kill Studies for Antibacterial Claims
Pig Skin In-Vitro Studies for Antibacterial Claims
Zone of Inhibition Screening for Antimicrobial Properties
Water Testing USP
Environmental Monitoring
Water Validation Protocols, IQ, OQ, PQ, and PM
Equipment Validation, IQ, OQ, PQ, PM, and Cleaning

Regulatory & 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