The 3E Principle: Key Considerations for Selecting and Outsourcing to a Vendor

Oct 1, 2014

Influenced by forces such as macroeconomics, politics, regulations, population growth and aging, there has been a major shift in the way biopharmaceutical companies conduct business. There is ever-increasing pressure to comply with evolving regulations along with cost reductions in order to grow business. Dr Chitra Lele of Sciformix Corporation outlines the “3E Principle” of Effectiveness, Efficiency and Economics; key parameters organisations should consider when selecting an outsourcing partner to assist with knowledge-based activities in drug development and post-marketing stages of the product lifecycle. ...

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The Interim Exec Community calls for a ‘Conscious Coupling’ of RPOs and Interims Specialists

Oct 1, 2014

Pharmaceutical companies have widely adopted strategies to outsource elements of their business operations, as part of an ongoing drive to deliver a more flexible model that unlocks cost efficiencies and alleviates some aspects of risk associated with drug development. As Dafydd Wright, Director of Interims of RSA, explains, recruiting talent is one such element. However, pharmaceutical companies should be wary of saving on recruitment at the risk of missing out on the best candidates, particularly when it comes to senior staff. ...

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Regulatory Scenario of Herbal Medicines: A Global Review

Oct 1, 2014

In the last few decades there has been exponential growth in the field of herbal medicine and regulation of herbal medicines has become key to ensuring the safety, efficacy and quality of herbal medicinal products. In their paper, Balamuralidhara V., Shilpi Khattri, Vandana K. and T. M. Pramod Kumar of JSS College of Pharmacy, JSS University, Mysore discuss in detail herbal drugs regulations in India, providing also an overview of the regulatory status of herbal medicine in the USA, Australia and Europe. ...

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Accelerating the Development of Generic Pharmaceuticals: Developing an Analytical Toolkit Suitable for De-Formulating Complex Reference Products

Oct 1, 2014

In its report “Critical Path Opportunities for Generic Drugs”, the FDA emphasises the need for advances in the field of analytical sciences in order to accelerate the development of generic products. Here, Gurfateh Singh and Paul Kippax of Malvern Instruments highlight techniques that are especially helpful in the de-formulation of complex reference products, focusing on triple detection Size Exclusion Chromatography (SEC) and Morphologically-Directed Raman Spectroscopy (MDRS). ...

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