Why is Regulatory Affairs important in Pharmaceutical and biotechnological Industry?
In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence the company’s success.The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the pharma company. Inadequate reporting of data may prevent a timely positive evaluation of a marketing application. A new drug may have cost many millions of pounds, Euros or dollars to develop and even a three-month delay in bringing it to the market has considerable financial considerations. Even worse, failures to fully report all the available data, or the release of product bearing incorrect labelling, may easily result in the need for a product recall. Either occurrence may lead to the loss of several millions of units of sales, not to mention the resulting reduction in confidence of the investors, health professionals and patients. A good Regulatory Affairs professional will have a ‘right first time’ approach and will play a v
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