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Regulatory Focus™ > News Articles > Strategic Use of Drug Master Files by Smaller Pharmaceutical Companies

Strategic Use of Drug Master Files by Smaller Pharmaceutical Companies

Posted 01 December 2010

Pharmaceutical companies undertake drug development to bring a valuable product to market and to provide returns to shareholders. As drug development proceeds, research and development costs grow exponentially and business risk progressively increases. Small to mid-size pharmaceutical companies are, therefore, constantly looking for ways to attract funding to reduce this risk. Funding is often secured through various collaboration arrangements initiated and negotiated by a company's business development department and senior management. In early negotiations, details such as the existence of a Drug Master File (DMF) are not necessarily considered. However, forwardthinking technical and regulatory leaders can add real value to the final deal if they consider how to manage their intellectual property (IP) in advance, perhaps by use of a DMF, and may be able to influence the deal at an early stage. This article provides some food for thought about the use of DMFs by small to mid-size pharmaceutical companies to strategically manage IP.


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