Advancing Global Active Pharmaceutical Ingredients (APIs)
Cytonova Labs is a premier partner for Active Pharmaceutical Ingredients (APIs), integrating CRO and CDMO expertise for oncology. Our CRO services drive discovery and lead optimization, while our CDMO capabilities facilitate seamless process development and tech transfer. This end-to-end framework ensures that from molecular design to large-scale cGMP manufacturing, every API meets the highest purity and clinical criteria.
Who We Are
Leaders in Complex API Molecular Engineering
Cytonova Labs serves as a vital bridge between innovation and market, operating as a full-service CRO and CDMO. In our CRO capacity, we handle API discovery and analytical development; as a CDMO, we execute large-scale synthesis of high-potency molecules, ensuring robust API structural integrity.
What We Do
Integrated API Design & CDMO Services
We provide end-to-end support for Active Pharmaceutical Ingredients (APIs) via our integrated CRO and CDMO model. Our CRO teams focus on lead optimization and analytical validation, while our CDMO operations manage scale-up and commercial production of high-potency APIs for life-saving oncology therapies.
Global Reach: US, EU & Asia
Strategic API Authorization Across 50+ Nations
We enable international access to oncology APIs by aligning our CRO data and CDMO manufacturing exports with global pharmacopeia standards. By utilizing specialized tech transfer protocols, Cytonova Labs maintains a compliant supply chain for APIs that meets the complex needs of healthcare systems globally.
API Quality, Compliance & Regulatory Strategy
Superior cGMP Assurance for Complex API Supply
Our global QMS ensures ICH compliance for all APIs, backed by rigorous CRO analytical oversight and CDMO process control. We provide sponsors with comprehensive CMC documentation and data integrity, ensuring a smooth regulatory pathway for the commercial manufacturing and launch of high-potency APIs.
Global Quality Certifications
WHO-GMP
cGMP Compliant Manufacturing
US FDA
Regulatory Readiness & Audited
EMA
EU GMP Compliance Standards
ISO 9001
API Quality Management System
ISO 13485
Specialized Quality Controls
API & CDMO Quality Ops
- We operate in strict adherence to ICH Q7 standards, maintaining a robust QMS that integrates cGMP frameworks validated through rigorous US FDA and EMA inspections. Our CDMO pipeline leverages Quality by Design (QbD) principles as outlined in ICH Q8–Q11, ensuring critical quality attributes (CQAs) and process parameters (CPPs) are optimized for complex oncology APIs. We implement a three-stage lifecycle process validation strategy and risk-based validation of all analytical equipment to secure ALCOA+ data integrity compliance. By generating comprehensive CMC dossiers, detailed impurity profiling, and stability data, we ensure regulatory submission readiness and expedited global market entry for high-potency substances.
Manufacturing & Research Excellence
High-Potency API Synthesis & Tech Operations
Our facilities provide high-containment cleanrooms for high-potency APIs. By blending CRO-level analytical precision during lead optimization with CDMO efficiency during commercial scale-up, we provide a reliable supply of oncology molecules, ensuring consistent quality throughout the API lifecycle.
API Synthesis and Scale-up
Our CDMO platforms utilize advanced process chemistry for the scale-up and commercial manufacturing of APIs, ensuring high-yield delivery of high-potency oncology substances with technical speed.
Sterile API Finishing
CRO API Discovery & Leads
Global API Batching