Life Sciences

As drug, biologic and medical device makers continue to right size their organizations, outsourcing of clinical trials has become very common. In fact, it is now a strategic imperative. Complex trials and global patient populations, quality and compliance concerns, along with continuing cost and competitive...

The life sciences industry is full of complexities, evolving technology, and uncertainty. Regulatory frameworks are becoming stricter and more complicated.  Companies are under more pressure to deliver results to shareholders. In order to be successful, the sector needs to embrace this culture of change by...

For those of you who know what 508 Compliance is, you understand why this is an important subject. For those of you who shuddered when you read the subject line, this post is for you. Although the Annual Enrolment Period (AEP) for US Healthcare companies is a...

Life sciences is one of the most active sectors for mergers and acquisitions (M&A), particularly medical devices. In 2017 the top ten biggest medical device deals totaled $65 billion; in 2016, 317 M&A deals totaled $46 billion. Notable recent mergers include Abbott acquiring St. Jude Medical...

As a regulatory professional, you face challenges on all sides: quicker time to market, finding the right providers to support you, and guiding various teams at each stage of a new drug’s life cycle, from conception through post-market reviews. With a medical device market estimated at...