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European Pharmaceutical Contractor
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Outsourcing of clinical activities has become a complex and expensive business with inherent risks that could, if continued in a haphazard manner, lead to the squandering of resources, both in terms of money, product registration time and personnel time. The tactical (on an individual project basis) and isolationist (limited involvement of functional groups) nature of the approaches by pharmaceutical companies toward clinical outsourcing may reduce the value that they derive from the process.
This article aims to look at the core processes involved in the selection of a CRO partner, whether a sponsor decides to approach the process in a tactical or a strategic manner. The article will describe and suggest how best to structure the sponsor's outsourcing teams to maximise the returns on investment. There should be a focus on quality in the selection process. Quality will then dictate the acceptable price. The current focus is on price, which has produced variable quality in terms of contractual delivery and regulatory acceptability.
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FT Global Pharmaceutical and Biotechnology Conference 2008
2-3 December 2008, The Cumberland, London
FT Global Pharmaceutical and Biotechnology Conference is Europe’s pre-eminent industry event attended by leading executives, government decision makers, investors, analysts and other specialist providers. It provides a unique platform to present new perspectives,’ feel the pulse’ of the industry, and network with peers across the sector.
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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