Unparalleled Quality Management System for Pharmaceutical Research

Synomics Pharma’s comprehensive quality management system has been internationally recognized by authorities and experts as an industry benchmark. Our highly-trained scientists and industry experts have worked together to develop a fully integrated GLP and cGMP quality management system for pharmaceutical research that assures reduced regulatory risk without adding inefficiencies or costs. This quality management system integrates the principles from recent FDA and AAPS initiatives for bioanalysis for clinical trials, bridging the regulatory requirements from pre-clinical to commercial development.

Synomics Regulatory History

• Synomics is FDA registered and regularly inspected for operations and PAI for NDA submissions
• DEA licensed, schedules I – IV, analytical
• GLP/cGMP bioanalytical support for preclinical and clinical studies
• cGMP analytical support for method development, method validation, stability studies, sample analysis, regulatory submissions and post approval lot release

Synomics Pharma understands the importance of deadlines. With our unparalleled quality management system, we save time by getting it done right the first time.