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European Biopharmaceutical Review

Challenging Change

From widespread commercial pressure as legacy pharmaceutical products come off patent, to the financial and strategic pressure of globalisation, pharmaceutical companies are currently undergoing a huge phase of evolution. Small enterprises and companies are being taken over by larger multinationals in an attempt to maintain a ‘healthy pipeline’. Scientific pressures manifested in recent advancements in technology have led to an expansion in the types of treatments available. Amongst these changes, it is imperative that manufacturers ensure the safety and quality of their therapeutic treatments. It is as significant that organisations do not leave themselves vulnerable to compliance issues and critical audit actions by the regulators.

PHARMACEUTICAL COMPLEXITY

The manufacturing process of a pharmaceutical product is an extremely complex model. On average, the active substance (API) makes up to approximately five to 15 per cent of the composition of finished product; with the rest of the components, a varied assortment of excipients is used. Typically, pharmaceutical APIs combined with excipients produce drug dosages specifically designed for the prevention and treatment of disease.


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Ilesh Sanathra has a BSc in Pharmacology and extensive experience in pharmaceutical and biotechnological submissions to national and international regulatory agencies. He was pivotal in setting up and maintaining a regulatory change control process in a blue chip pharmaceutical company. Currently Ilesh works for the leading consultancy company, Pharmalink Consulting Ltd.
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Ilesh Sanathra
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