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Business Description

Cryologics specializes in microbiological techniques used to prepare and cryopreserve (“freeze”) microorganisms into a standardized format (concentration).  A pharmaceutical or biotechnology client submits its in-house microbial isolates to Cryologics, which will culture them and convert them into a customized product.  Converting the client’s in-house microorganisms into this format enables the client to use them in a wide variety of QC testing required by regulatory agencies.

Compliance

Mission Statement

Our mission is simple….

To provide services and products in strict compliance with current Good Manufacturing Practices, in a timely manner, and at a straightforward and competitive price. We believe our role is not simply a supplier, but to partner with our clients as fellow microbiologists for the goal of meeting their needs.

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Corporate Management

Bob has 30 years of experience in the GMP industry, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs. He has worked for biotechnology and pharmaceutical manufacturers, as well as for pharmaceutical, biotechnology, cosmetic, and food contract testing laboratories. He has played key roles in numerous U.S. and international regulatory inspections.

 

He holds a Master of Science degree from Temple University in Quality Assurance / Regulatory Affairs. He is Regulatory Affairs Certified (RAC), and is a Certified Manager of Quality / Organizational Excellence (CMQ / OE). He is a member of the Pharmaceutical Microbiology Forum (PMF), the American Society for Microbiology (ASM), the Parenteral Drug Association (PDA), the Regulatory Affairs Professional Society (RAPS), and a Senior Member of the American Society for Quality (ASQ). View his LinkedIn profile for a detailed summary of his qualifications.

Bob Westney, M.S., RAC, CMQ/OE
President
Director of Quality and Operations

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