Quality Assurance & Control
At Abiozen, quality is not a checkpoint—it is a culture embedded across every phase of our manufacturing lifecycle. We deploy rigorous quality assurance and control frameworks to ensure every super generic API meets or exceeds global standards for safety, efficacy, and regulatory compliance. Our systems are modeled on best practices from leading industry players and tailored to support global market success.
Advanced Analytical Testing
Our dedicated QA/QC laboratories are equipped with advanced instrumentation including high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS). These technologies enable precise identification, quantification, and characterization of active ingredients and impurities. Complemented by real-time monitoring and digital validation, our analytical testing ensures that every API lot adheres to critical quality attributes—reflecting Curia Global’s emphasis on analytical excellence.
Stability Studies
We conduct comprehensive stability testing under ICH-recommended conditions to assess the shelf-life and environmental resilience of our APIs. These studies simulate real-world storage and distribution scenarios, validating that our products maintain their quality and efficacy throughout their lifecycle. This approach is aligned with Thermo Fisher Patheon’s strict compliance protocols and global regulatory expectations.
Comprehensive Audits and Continuous Improvement
Our internal and external audit programs are structured to identify deviations, implement corrective actions, and drive ongoing enhancements across systems and processes. Inspired by Thermo Fisher CRDMO’s commitment to continuous improvement, we maintain an active quality culture that prioritizes traceability, transparency, and operational excellence.
Commitment to Compliance and Client Confidence
Abiozen’s unwavering dedication to quality ensures regulatory alignment and instills confidence among global partners and health authorities. Every API we deliver is supported by robust documentation, validated testing, and a commitment to excellence—establishing us as a trusted supplier of high-integrity pharmaceutical ingredients.
Connect with Abiozen
We thrive on tackling complex challenges—and we’d love to learn about yours. Reach out to explore how we can support your program’s unique requirements.
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