Synergy Bioscience

We are deliberate in our approach and focused in our execution. We strive to make continuous improvements. SERVICES WE PROVIDE TO OUR CLIENTS: Quality Systems Development and Optimization CAPA &Root Cause Analysis Investigations Consent Decree & Warning Letter Remediation Post-Market Surveillance & MDR & Recalls Process Analysis & Continuous Improvement Quality System Gap Assessment&Risk Management GMP & CAPA & Validation Training Clean Room &Environmental Monitoring Program GMP / GLP / GCP Auditing Programs Analytical Method Development & Validation Supplier Qualification& Audit Management Chemistry, Manufacturing, and Control (CMC) Support Extractable&Leachable Studies in Our State of the Art Laboratory Cleaning Process Validation Lean Six Sigma Project Establishment and Management Pharmaceutical Batch Record Establishment and Review Inhalation Process Validation Facility and Equipment Qualification (IQ/OQ/PQ) Sterilization Process Validation Endotoxin Testing Bioequivalence Testing Lyophilization (Freeze-Dry) Validation Studies Drug Product Stress Testing & Stability Studies Therapeutic Protein Formulations OUR MISSION