Regulatory Matters – The Life Sciences EIM Blog

Life science companies, such as pharmaceutical, biotech, diagnostic, food quality, and cosmetic, operate in a highly regulated and rapidly evolving environment. Their operations are both data and document-intensive. Recent demands for increased public accountability against a trend of fewer new products and expiring patents are threatening traditional profitability and revenue growth. Business leaders are tasked with transforming their organizations into innovation centers while maintaining tight regulatory compliance with emerging governmental guidelines such as the US Drug Supply Chain Security Act and the EU’s Regulation (EU) No 1235/2010 . CIOs must enable disparate and often distally located departments to share key information among team members and make the best decisions possible,
while dealing with vast amounts of data and information often housed within legacy systems.

Organizations that can streamline drug pre-approval processes will have a greater advantage in meeting the challenges posed by emerging regulatory requirements. Streamlining will allow for more investment in research, the development of more candidates, the approval of more drugs in more regions, and the ability to reduce risk. An enterprise strategy for content management results in quicker time-to-market on patented drugs by automating review and approval steps and enabling more rapid creation and submission of regulatory applications.
Opportunities for improvement also lie in the areas of distribution, sales, and marketing.

How do we improve innovation and growth while maintaining regulatory compliance? Patent expirations and the increasing failure rate for candidates in the pipeline has greatly reduced life science companies’ ability to grow organically. It is estimated that over 150 billion dollars in sales will be lost to pharmaceutical patent expirations by 2018! Additionally, regional price controls on new and existing medications and challenges in marketing pharmaceuticals abroad have further eroded the lifetime value of a drug for these companies. In order to stay competitive and avoid large punitive actions and fines, life science organizations have become increasingly proactive, rather than reactive, in addressing these key areas.

The goal of this blog is to discuss emerging regulations and other challenges related to the life science industry and how EIM can help life science organizations maintain regulatory compliance and information governance.

I hope you find this blog useful in your daily work. If you’re interested in hearing about how OpenText solutions can help with specific regulations,
please comment below or email me at jshujath (at) and I will write about it in a future blog.

Stay tuned for the next blog on the US FDA’s Drug Supply Chain Security Act.

Jaleel Shujath

Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

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