Regulatory & Compliance

What You Need, When You Need It

EVERSANA has a proven track record of providing best-in-class regulatory and quality support at any phase of the product lifecycle to companies focused on rare disease; medical device; pharmaceutical; biologic; and human cells, tissues, and cellular- and tissue-based products (HCT/Ps).


By navigating the ever-changing global regulatory and quality landscape and by delivering customized solutions and strategic guidance to expedite approvals, EVERSANA can help you increase speed to market and maintain or regain compliance. Regulatory and Quality play key roles in EVERSANA’s integrated life science compliance model, providing the key to future-proofing public health. This holistic model is led by experts with deep domain experience and driven by an integrated process and technology and world-class compliance data analytics, which provides real-time insight that drives productivity and reduces errors and cost. For more information on Integrated Compliance solutions, visit

EVERSANA has a bias for action, not simply advice. Whether it’s short-term assistance or a long-term relationship, we will partner with you to facilitate patient access to your novel products and therapies while positioning you for maintaining compliant systems, procedures and products.


Diverse Backgrounds

Our experts leverage their diverse backgrounds to provide the regulatory and quality support needed to help you achieve your goals/objectives throughout the product lifecycle. We seamlessly integrate with your team to optimize your regulatory strategy, quality system and operational processes. Our diverse technical background allows us to support companies in numerous therapeutic areas.

The role of compliance in securing the safety of products is an extremely important and integral part of the entire product life cycle and poses one of the biggest challenges for pharma device and tissue manufacturers who want to invest energy and focus on driving value, innovation and patient centricity. We work with our customers – from developing strategy and direction to setting up functions, business processes and execution capabilities/services – to provide a strategic balance between compliance risk and value.

EVERSANA’s Regulatory and Quality Solutions include five core areas of expertise:

Need Advisors Focused Exclusively On The Life Sciences Industry?

We can help you address strategic, tactical and operational concerns to increase value across your entire product life cycle.