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Implementing Process Validation Guidances
By Peter H. Calcott, Ph.D., President, Calcott Consulting LLC
Published March 6, 2013
Complying with FDA and EU for small and mid-sized companies Read More »
Aseptic Processing Validation
By Ross Acucena and Randy Wilkins
Published April 4, 2012
Best practices for sterile filtration validation of re-use and extended-use processes Read More »
Published February 27, 2012
Establishing, through documented evidence, a high degree of assurance that a specific process will consistently yield a product that meets predetermined specifications and quality characteristics.… Read More »
Aseptic Process Validation
By Tom Spurgeon
Published November 3, 2006
Is a new FDA guidance imminent? Read More »
Xcelience
By Sharon L. Burgess, Senior Vice President, Business Development
Xcelience offers a suite of services enabling clients to partner with a single CDMO for all of their clinical outsourcing needs. Services include preformulation, analytical services, formulation development, GMP manufacturing, small-scale commercial… Read More »
Patheon
By Kelly Ormsby
With a commitment to quality, scientific excellence and exceptional customer experiences, Patheon is the world's leading provider of contract drug development and manufacturing services. Through an integrated global network of facilities, we give… Read More »
By Claire Ruzicka, VP Sales
Rottendorf Pharma GmbH
By Rottendorf Pharma GmbH
Rottendorf Pharma is a worldwide operating Technical Operations Organization for development, manufacturing and packaging of solid dosage forms. We offer the complete range of services according to customer needs assuming Total Process Ownership on e… Read More »

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