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Stature for Pharmaceuticals & Biotech
	“Biotech and Pharmaceutical companies face significant challenges in cost-effectively meeting growing regulatory requirements while innovating new medicines to improve patient health. Complying with regulatory bodies like FDA and EPA and regulatory standards such as ICH, GMP, ISO and OSHA increases time-to-market and requires increasing levels of effort. The cost to develop new drugs increased by 60% from 2001 – 2006 with only a small percentage of new marketed products ever returning their initial R&D investment. At the same time, generic drugs have been eroding branded drugs market share – a 33% increase from 2003 to 2008. Government and healthcare provider policy changes to reduce costs have been a major factor in this trend, in addition to expiring branded drug patents. The Biopharmaceutical industry challenge is to streamline the regulatory compliance process – improving conformance to regulations & standards, yet at the same time reducing the cost of compliance activities.”
	Keywords: Stature, Pharma Language: Format: PDF Size: 1573 KB