BioVenture Consulting Adds Capabilities to Better Serve Biomedical Industry; Regulatory/Compliance Experts Now ISO 9000 Certified Auditors.FREMONT, Calif.--(BUSINESS WIRE)--Nov. 6, 1995--BioVenture Consulting Inc., a company dedicated to providing comprehensive operations expertise to biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. companies, today announced increased capabilities in the form of preparation for ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9000 certification. ISO, or International Organization of Standardization International Organization of Standardization, n.pr a nongove-rnmental federation of worldwide bodies that publishes international agreements covering a broad range of services and technologies to promote the use of common standards across the world. , criteria measure quality levels associated with product manufacturing and are important to medical device companies exporting to the European Community. "This preparation for ISO 9000 registration is significant in terms of what we can now offer our clients," said Jean LaDouceur, president of BioVenture Consulting. "In addition to helping companies with regulatory and compliance issues for domestic markets, we can now serve as an important resource to companies in broader, international arenas." Besides targeting companies with global markets, BioVenture Consulting now appeals to more companies that want to increase their reach, improve their customer satisfaction ratio and establish a reputation of being committed to quality. LaDouceur explained that this is accomplished through assessment of the quality management system in place, preparation of a quality manual based on GMPs and ISO 9000 as well as BioVenture's close cooperation with employees of the client company in the preparation of quality system documents. BioVenture Consulting offers a variety of services in the regulatory, compliance, manufacturing and operations areas. Specific projects of interest include GMP GMP (guanosine monophosphate): see guanine. and GLP See gateway location protocol. audits; resolving staffing issues in the areas of manufacturing, quality and validation; acting as a liaison with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and assisting due diligence Research; analysis; your homework. This term has caught on in all industries, because it sounds so "wired." Who would want to do analysis or research when they can do due diligence. See wired. teams with compliance matters. Serving the biomedical industry exclusively, Fremont, Calif.-based BioVenture has consulted with major pharmaceutical and medical device companies and has conducted audits requested by the FDA. The company's president, Jean LaDouceur, has over 15 years of experience in the manufacture and quality assurance of biomedical products. CONTACT: BioVenture Consulting Inc. Jean LaDouceur, 510/651-9196 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion