Current Edition

Exploring the Opportunities and Challenges in Repurposing a Master Dossier

It is known that developing an innovative healthcare product from bench to market is a very expensive and complex effort, as the pharmaceutical industry is highly regulated to protect the consumer. Global spend on medicines is forecast to reach nearly $1.4 trillion by 2020, an increase of about 32% over 2015. This is driven by population growth and improved access to emerging markets. Interestingly, the revenue driver at many leading companies remains the innovative medicines portfolio, despite some companies diversifying into generics, consumer medicines, diagnostics and other related healthcare products. Bindu Narang, Director of Scientific Writing Regulatory Affairs, with Dr Rajendra Wable, Regulatory Writing Coach, Scientific Writing and Regulatory Affairs at Sciformix Corporation, explore the opportunities and challenges in repurposing a master dossier.