quality
Quality at Aster begins well before any manufacturing activity takes place. Each partner undergoes a rigorous, multi-stage qualification process that includes technical assessment, regulatory verification, ethical compliance checks, and evaluation of facility standards. Only after meeting our predefined criteria—across safety, governance, and operational capability—are manufacturers selected to enter our supply network.
Our commitment does not stop at onboarding. Partners are continuously monitored through audits, performance reviews, data traceability systems, and ongoing compliance evaluations. This allows us to maintain consistency, uphold global quality benchmarks, and ensure that every product delivered under the Aster umbrella meets the highest standards of reliability, safety, and regulatory integrity.
We assist clients with
GMP certificates and site master files
We work day and night to solve the problems that can help them move forward for those who is seeking answers!
DMFs, CEPs and letters of access
Our team typically processes over 3 million patient every month and fifty of the top drugs developed in 2022.
Analytical methods and impurity profiles
Our team typically processes over 3 million patient every month and fifty of the top drugs developed in 2022.
Tech transfer documentation
Tech transfer documentation and support for filings (IND, NDA, ANDA and global equivalents)
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
Partnering for Through our investment in new high volume chemistry tech, we have brought next generation.
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
We ensure material provenance, compliance assurance, and full traceability across every movement.