Biotest Laboratories, Inc. Our company was organized by Gregg A. Mosley in 1988 as a test laboratory for manufacturers of medical products. To meet growing customer requests, it has developed areas of: Laboratory Testing, Contract Manufacturing, Packaging/Assembly, Contract Steam Sterilization, Cleanroom/Cleanbench Testing and Certification, Validation Services, Microbial Management (Evariology), Training and Consulting Services Class 7 and Class 5 areas are available for manufacturing/assembly, as well as cleaning and passivation lines for various types of implantable devices and drug delivery systems. Mr. Mosley, an internationally recognized authority in GMP compliance, sterilization and manufacturing of sterile medical products, serves as a consultant to the pharmaceutical and medical device industry in the area of process validation and sterilization. He has authored papers and collaborated in presentations and courses for the FDA (Food and Drug Administration), the PDA (Parenteral Drug Association), Medical Device and Diagnostic Industries (MD & DI), American Society of Microbiology (ASM), and workshops for the International Society of Pharmaceutical Engineers (ISPE). He has served on the USP XXII sterilization indicators expert advisory committee for the microbiology and biochemistry section, and on several sterilization standards committees at AAMI and related US Sub-TAG working groups for ISO. He is co-chair for both the AAMI Biological Indicator and the Industrial Moist Heat Sterilization committees. Mr. Mosley is the lead instructor for the AAMI Industrial Sterilization of Medical Devices. He is also former co-chair of Minnesota's Medical Alley, Regulatory Special Interest Group. The cornerstone of the relationships with our customers is to provide quality services. It is our fundamental belief that our quality system should equal or exceed the system of our clients. Therefore, we are, by our own design and by regulation, your business partner in the manufacturing of your company's products. We seriously recognize our responsibility and accountability in this endeavor and as we contribute to your business success we do thereby contribute to our own.