Provide CRO services for innovative drugs
To meet the needs and requirements of our global customers by providing safe and effective pharmaceuticals, where the quality is built into our products; by implementing a robust and active quality system that ensures all operations comply with the Current Good Manufacturing Practices and contemporary regulatory requirements and exploits any advancement in technology to provide better services to the society and humankind at large.
Quality of Personnel
Quality of Performance
Quality of Product
Good Manufacturing Practice for Drugs (2010 Revision) (Ministry of Health Decree No.79)
Current Good Manufacturing Practice, Code of Federal Regulations, Title 21, Food and Drugs, Parts 210&211
ICH guidelines, etc.
①Facilities & Equipment System ②Production System
③Material Management System ④Laboratory Control System
⑤Packaging & Labeling System ⑥Quality System
The Quality System is the central system that lays down guiding principles for the other systems, and the other systems merge into the Quality System. The Quality System defines and controls the GMP implementation and documentation in each of the other five systems.
The manufacturing facility and Quality Management system in NOVAST comply with the International GMP standards. The US FDA has successfully inspected NOVAST for CGMP compliance with zero 483 observations during the last 5 inspections in 2013, 2015, 2016, 2017, and 2018.
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