network-capabilities
Our manufacturing network comprises a carefully curated group of global partner facilities, each selected for strong regulatory credibility, advanced technical depth, and consistent compliance delivery. Together, they enable seamless progression from early development to regulated commercial supply across multiple geographies and therapeutic categories.
Strategic Manufacturing Network
Our partner facilities are built around regulatory strength, analytical depth, and scalable assets,ensuring reliable supply for global markets.
Hold leading international approvals including USFDA, EDQM, WHO-GMP, PMDA, EU-GMP and other national authorities.
Operate robust, ICH Q7A-aligned quality and documentation systems, ensuring global regulatory readiness.
Provide full-scope analytical capability with HPLC, UPLC, GC, LC-MS, NMR, ICP-MS, stability systems and impurity profiling.
Cover the full scale range from kilo labs and pilot plants to multi-ton commercial assets for seamless scale-up and tech transfer.
Maintain disciplined EHS frameworks with solvent recovery, waste minimization and green-chemistry aligned operational controls.
Ensure consistent, on-time delivery through robust global sourcing, qualified vendor networks, advanced planning systems and end-to-end supply chain visibility.
Quality at Aster starts long before the first batch is produced
Our Quality Framework
Every partner undergoes a structured, multi-stage qualification program designed to validate technical competence, operational integrity, and regulatory alignment. The process includes GMP audits, documentation reviews, compliance checks, and verification of quality systems to ensure readiness before onboarding.
Once approved, partners are monitored continuously through periodic audits, data trend evaluations, and performance scorecards. This ongoing oversight ensures sustained compliance, consistent product quality, and alignment with global regulatory standards throughout the lifecycle of engagement.
Initial regulatory & licence screening
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Technical and quality system audits
We validate manufacturing capability and GMP alignment
DMF/CEP and site documentation verification
We confirms transparency, traceability, and dossier readiness.
Ongoing regulatory intelligence & risk monitoring
We track changes in compliance status and market expectations.
Batch documentation and CoA review
We confirm product integrity and release compliance for every batch.
Supply chain transparency and trace audits
Ensure on-time delivery via global sourcing, qualified vendors, robust planning and more seamless end-to-end supply visibility.