We are committed to delivering the highest quality in every batch of materials that we release to our sponsors and customers. Our quality system is established to ensure strict conformance to ICH guidelines and GMP requirements, controlling from incoming materials, manufacturing operations, in-process control, final product release to stability monitoring.
Regulatory Support
We support our sponsors and customers with Drug Master Files (DMF) and assist them with CMC preparation for IND, ANDA or NDA filings.
Audit and Certification
Trusted by eighteen US-based NCE drug developers and audited by five of them, our facilities are currently certified for ISO 9001 quality management, ISO 14001 environmental management and ISO 45001 occupational health and safety management. We aim to schedule a GMP inspection by the Taiwan Food and Drug Administration (TFDA) in about a year. As we expand our collaboration with more pharmaceutical companies globally, we are confident and determined to meet the standards and requirements of high quality drug substances in all markets.
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