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Faced with unrelenting competitive pressure to bring products to market and produce them competitively, pharmaceutical companies have created a new business model that relies on outsourcing, acquisitions and strategic partnerships.  That model relies on a supply chain of subcontractors, API suppliers, vendors and facilities to produce finished products.  Each link in the supply chain creates vulnerability to the ability of finished pharmaceuticals to meet US FDA quality requirements. 

The FDA, in establishing a secure supply chain pilot program, has stated, “The existing US supply chain system is not adequate to meet challenges presented by globalization.  Kaplan EduNeering’s solutions facilitate that management of quality and consistency across our clients’ supply chain, from API manufacturing through CMOs.  Since our technology is provided as Software-as-a-Service (SaaS), the sponsor company can leverage existing technology throughout the chain, without requiring entry behind the company firewall.  Our curricula and SOP management suite is readily transferrable and is used by worldwide CMOs and CROs today to support that commitment to quality.