Digitization of regulatory affairs: how to maintain compliance

An Expert View piece from Cecile Riboud, senior director of decentralized trials and integrated global compliance solutions at IQVIA, on the best way to maintain regulatory compliance in a virtual working model.

The pharmaceutical ​​industry is faced by a multi-dimensional challenge of revenues under pressure, increasing regulatory requirements which differ across localities, dispersed data sources, innovation in technology and staffing pressures.

The pandemic’s forced push to a virtual operations model is causing a greater reliance on technology to ensure effective and practicable processes.

This leaves pharmaceutical companies struggling to answer the question of how their firms can obtain and maintain regulatory approval of newly developed and commercialized products in the fastest, most efficient and effective manner possible.

Regulatory expertise among their teams is critical. This knowledge base cannot be emphasized enough as these individuals provide unique experience in managing and transforming regulatory data to minimize risk of non-compliance and delayed product market approval.

However, with these experts in high demand, they must be effectively leveraged at all times. Technologies such as automation and AI are helping to overcome the challenge in supporting regulatory specialists in their day-to-day operations, refocusing their expertise on strategic and business critical issues.