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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 »
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 »
By Shamik Pandit
Published August 23, 2005
How the DOE approach can smooth the process 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 »
Alliance Medical Products
AMP, a Siegfried Company, provides contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices. Our cGMP, scalable aseptic fill/finish suites support clinical… Read More »
By Claire Ruzicka, VP Sales
DPT Laboratories
By Stacy London
With a specialized focus on semi-solids and liquids, DPT offers pharmaceutical companies the broadest range of capabilities in the industry. From R&D formulation to commercial-scale manufacturing, small batches to large, liquids to emulsions, sterile or non-sterile, we offer clients of all sizes the most effective resources for meeting challenges. Read More »
By Bob Forner, Marketing Manager


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