cGMP Services
As your Active Pharmaceutical Ingredient (API) progresses from the laboratory research phase to clinical trials, Raybow USA stands ready to support you with rapid, efficient, and economical cGMP synthesis.
Advanced cGMP Synthesis Laboratory
Raybow USA’s cGMP synthesis laboratory handles a wide array of chemical processes.
Glass reactors capable of accommodating up to 72 liters ensure precision and quality control for each batch.
Synthesis chemists involved in the process development remain engaged into cGMP production, providing project continuity.
FDA-Inspected Facility with Proven Track Record
Raybow USA facilities are routinely FDA inspected and client audited.
Comprehensive Range of cGMP Services
API Synthesis for Clinical Needs: From milligram to kilogram scale, accommodating the varying needs of early phase clinical studies.
Process Validation: Ensuring that every stage of the API production is efficient, compliant, and reproducible.
Impurity Management: Including isolation, characterization, and synthesis of impurities.
Analytical Development and Validation: Creating and validating methods for accurate API analysis.
Reference Standard Services: Preparing, characterizing, and documenting reference standards.
ICH-Guided API Stability Studies: Conducting comprehensive stability studies in line with ICH guidelines.
Product Release Testing: Rigorously testing to ensure the quality and safety of the API.
Raybow USA and other Jiuzhou Pharma facilities are equipped to synthesize API Clinical Trial Material, catering to both clinical studies and commercial production.
