Quality

Bioserv’s integrated approach to quality through our one Quality System and strategic quality plan, together with our culture of continuous improvement ensures compliance with the ever changing regulatory requirements. Our objective is to ensure total transparency of our quality processes.

Bioserv welcomes the opportunity to discuss the Quality System during on site customer audits.

Bioserv is currently registered with the United States Food and Drug Administration (U.S. FDA) for both Pharmaceutical and Medical Device manufacturing. The FDA Drug Center conducts annual inspections of the facility. Bioserv is currently licensed by the State of California for Pharmaceutical and Medical Device manufacturing.

Bioserv is also ISO 13485:2003 Certified (FM 77429). Although the scope of Bioserv’s ISO Certification is limited to Medical Devices at this time, Bioserv has one (1) Quality System that is used for both Medical Devices and Pharmaceutical production.

Questions?