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Biotest Laboratories, Inc Company Profile

10:23 EDT 26th September 2018 | BioPortfolio

Biotest Laboratories, Inc. was organized by Gregg A. Mosley in 1988 as a test laboratory for manufacturers of medical products. To meet growing customer requests, Biotest Laboratories has developed areas of:

  • 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 Biotest Laboratories, Inc.'s 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.

Biotest Laboratories, Inc. is committed to a program of quality processes, products and services.

 


Quality Systems

  • FDA, ISO 13485, EN/ISO 17665 registered, and  ISO/IEC 17025:2005 accredited
  • Good Manufacturing Practices (GMP) Compliant
  • Dedicated to the principle of continual improvement
  • Biotest Laboratories, Inc. is frequently audited as a vendor, by the FDA for GMPs and new product submissions, and for ISO applications & CE marks.
  • Mr. Mosley is listed as a qualified instructor for the AAMI/FDA Quality System regulation (QSr) course, and as an instructor/contributor for the AAMI Process Validation Requirements and Industry Practices course.

Location

9303 West Broadway Ave.
Brooklyn Park
Minnesota
55445
United States of America

Contact

Phone: 763-315-1200
Fax: 763-315-1201
Email: pschumann@biotestlabs.com


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PubMed Articles [162 Associated PubMed Articles listed on BioPortfolio]

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Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fasting Condition

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More Information about "Biotest Laboratories, Inc" on BioPortfolio

We have published hundreds of Biotest Laboratories, Inc news stories on BioPortfolio along with dozens of Biotest Laboratories, Inc Clinical Trials and PubMed Articles about Biotest Laboratories, Inc for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Biotest Laboratories, Inc Companies in our database. You can also find out about relevant Biotest Laboratories, Inc Drugs and Medications on this site too.

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