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 has inspected the facility for routine inspections. The FDA Device Centers have performed inspections of the facility for routine inspections and for pre and post market approval. Bioserv is currently licensed by the State of California for Pharmaceutical and Medical Device manufacturing, and for interstate commerce.
Bioserv is also ISO ISO 13485:2016 Certified (FM 77429). Although the scope of Bioserv’s ISO Certification is limited to Medical Devices at this time, Bioserv is one (1) Quality System that is suitable for both Medical Devices and Pharmaceutical production. The Company also produces sterile products compliant for use in the EU.