At Ceyone Life Sciences, quality assurance and regulatory support form the backbone of our manufacturing operations. Every product we deliver is developed and manufactured to meet the highest standards of quality, safety, and efficacy, backed by rigorous systems and continuous monitoring. Our dedicated regulatory team provides expert guidance across the entire product lifecycle—ensuring smooth navigation of complex compliance requirements and timely approvals. From IND filings to NDA, ANDA, and DMF submissions, we offer complete support to help our clients bring their products to market with confidence.
- Comprehensive Quality Management System (QMS)
- Robust QMS aligned with global regulatory guidelines (ICH, WHO, US FDA)
- Independent Quality Assurance oversight across all operations
- Continuous compliance monitoring, risk management, and internal audits
- Advanced Quality Control (QC) Laboratories
- Comprehensive testing of raw materials, in-process samples, and final APIs
- High-end instrumentation including HPLC, GC, LC-MS, FTIR, and UV-Vis
- Particle size analysis, solid-state testing, and heavy metal detection
- Impurity profiling, reference standard management, and method qualification
- Regulatory Filings & Technical Documentation
- Drug Master File (DMF) preparation and lifecycle maintenance (Type II DMF)
- CEP (Certificate of Suitability) compilation and support
- Section 3.2.S (CMC) dossier compilation for IND, IMPD, NDA, and ANDA
- Validation & Stability Programs
- Method validation protocols compliant with ICH Q2 guidelines
- Real-time, accelerated, and intermediate ICH stability testing
- Equipment qualification (DQ, IQ, OQ, PQ) and environmental monitoring
- Audit Readiness & Client Support
- Dedicated support for regulatory agency inspections and qualified client audits
- Transparent deviation, CAPA, and Change Control management systems
- Annual Product Quality Reviews (APQR) and continuous quality improvement
Why Choose Ceyone ?
Global Regulatory Alignment
Our quality systems adhere strictly to ICH Q7 guidelines, ensuring audit readiness and compliance with major global regulatory standards.
State-of-the-Art QC Infrastructure
Equipped with cutting-edge analytical tools and validated systems, our QC labs deliver accurate, reproducible, and compliant testing.
Complete CMC & Filing Support
From early development documentation to commercial DMF/CEP submissions, we handle full regulatory documentation lifecycle management.
Commitment to Data Integrity
Rigorous electronic and manual data integrity controls ensure transparency, traceability, and defensibility during audits.
Popular questions
What quality standards does Ceyone operate under?
Ceyone operates under current Good Manufacturing Practices (cGMP) in compliance with ICH Q7 guidelines for active pharmaceutical ingredients.
What regulatory filings does Ceyone support?
We support Drug Master Files (US DMF, Type II), Certificate of Suitability (CEP), and CMC modules (Section 3.2.S) for IND, IMPD, NDA, and ANDA submissions.
How does Ceyone manage stability testing?
We conduct comprehensive stability studies in accordance with ICH guidelines (Q1A–Q1E), covering accelerated, long-term, and intermediate climate conditions.
Can clients audit Ceyone's facilities?
Yes. We welcome client quality audits and offer complete transparency, hosting, and technical response support throughout the audit process.
What analytical instruments are available in Ceyone's QC laboratory?
Our QC laboratories are equipped with HPLC, GC, LC-MS, UV-Vis, FTIR, autotitrators, stability chambers, and advanced wet chemistry instrumentation.