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The impact of regulatory compliance on life sciences companies

On the quest to push the boundaries of innovation to develop and launch new products, companies have to address an increasing number of regulatory requirements which span multiple geographies, business activities and functions. While the life sciences industry has sustained growth and advances by drafting scalable compliance and business strategies that are flexible to the legal landscape, they continue to face challenges in growth, quality, and overall compliance. This is why identifying, analyzing and mitigating compliance risks are essential in developing an effective compliance strategy to help future-proof your business.


The word compliance has been the bane of existence for so many people partly because there is no common definition. It is defined as different things depending on the role and responsibility of each person. Traditionally, life science companies have tackled compliance by the individual needs of the organization or business functions resulting in a fragmented approach to each area developing its own discrete compliance agenda. In the era of Big Data, this has created a disjointed business environment where securing information is at direct odds with calls for greater transparency.

“Regulatory agencies have now placed a greater emphasis of ensuring product transparency and development efforts for the safety of patient population.  As product development efforts become much more advanced currently, the ability to overcome regulatory gaps becomes highly essential”


In a recent study by Deloitte, 43 percent of respondents do not believe that current compliance monitoring and reporting systems enable the ability to avoid or minimize the impact of non-compliance and only 19 percent agree that they have access to systems with the ability to provide more granular detail on specific issues upon request. In a perfect world, a single enterprise-wide system would have the flexibility to manage multiple products for various use cases. Unfortunately, this simply is not cost effective. Due to vastly superior data processing capabilities driven by the cloud, artificial intelligence (AI) and robotic process automation as well as exponentially increasing volume of real-world data generated by wearables, along with the Internet of Things, consumer technologies and social media, the role of the right data and technology will increase significantly over the coming years and will shape the future of the life sciences industry. This also means that key regulators such as the FDA and the US Department of Health and Human Services (HHS) have to increase oversight across the life science industry increasing approval times and making auditing more cumbersome.


The FDA does not allow compliance to overshadow quality. In fact, the FDA is spearheading a number of initiatives, such as Program AlignmentCase for Quality, and Transparency, to help shed light on the agency’s collaboration with the life sciences industry and the public.

Program Alignment – In 2014, the FDA created a new initiative called Program Alignment, a multiyear project aimed at helping the agency address new challenges specific to scientific innovation, increased biomedical discoveries, and globalization as it looks at managing those things in conjunction with its mandate as a public health agency.

The Case for Quality – In 2011, the FDA launched a major initiative (the Case for Quality) to join the medical technology industry in a collaboration to bring together manufacturers and regulators.  The goal was to focus on the design and manufacturing elements that will have the greatest impact on the improvement of product quality, increasing patient safety.

Transparency – The transparency initiative allows the FDA to provide information to the public about product approvals, new initiatives, and regulations violations for most regulated products by posting untitled letters and warning letters on its website. It has also begun publishing FDA Form 483 inspection summaries, and compliance and recall data.

It is no coincidence that companies in the life sciences industry have developed specialized needs to address the challenges it faces in the pursuit of not only quality issues and compliance requirements, but patient protection and transparency.  It is to address this challenges that companies like ours have sprung to facilitate the implementation of strategies and resources that make these challenges manageable and improve overall industry growth, compliance, and quality.  Because compliance is the foundation of product development and commercialization, following a framework within the companies to secure qualification for patients and realize commercial objectives has never been more important.

At Rubix LS, we look forward to helping you in achieving the highest levels of transparency, managing complexity within the industry, and aligning your quality outcomes to the current regulations.

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