Raybow's cGMP Services: Ensuring Excellence from Lab to Clinic
As your Active Pharmaceutical Ingredient (API) progresses from the research phase to clinical trials, Raybow stands ready to support you with rapid, efficient, and economical cGMP synthesis. Our facility is equipped to synthesize API Clinical Trial Material ranging from milligrams to multi-kilograms, catering to both clinical studies and low-volume commercial production.
Advanced cGMP Synthesis Laboratory Our cGMP synthesis laboratory is designed to handle a wide array of chemical processes. With glass reactors capable of accommodating up to 72 liters, we ensure precision and quality control for each batch. For larger quantities, we facilitate seamless transfers to large-scale cGMP manufacturers, maintaining the integrity and compliance of the process.
FDA-Inspected Facility with Proven Track Record Pride in our facility is backed by a strong regulatory record. We underwent our first FDA pre-approval inspection (PAI) in July 2009 and emerged with no Form 483 issued, a testament to our stringent adherence to quality and regulatory standards.
Comprehensive Range of cGMP Services Our cGMP services are comprehensive and include:
- API Synthesis for Clinical and Commercial Needs: From milligram to 1000+Mt scale, accommodating the varying needs of clinical studies and commercial production.
- Process Validation: Ensuring that every stage of the API production is efficient, compliant, and reproducible.
- Regulatory Support Documentation: Assisting in IND (Investigational New Drug), NDA (New Drug Application), and ANDA (Abbreviated New Drug Application) submissions with thorough documentation.
- Impurity Management: Including isolation, characterization, and synthesis of impurities.
- Analytical Development and Validation: Creating and validating methods for accurate API analysis.
- Reference Standard Services: Preparation, characterization, and documentation of reference standards.
- ICH-Guided API Stability Studies: Conducting comprehensive stability studies in line with ICH guidelines.
- Product Release Testing: Rigorous testing to ensure the quality and safety of the API before market release.
At Raybow, we are committed to supporting your journey from laboratory research to clinical success. Our cGMP services are designed to meet the highest standards of quality and compliance, ensuring that your API is ready for the critical stages of clinical trials and commercial production.