Maximize The Efficiency Of Regulatory Operations With Five Key Competencies

By Moshin Malik, Director, Parexel Regulatory Affairs

The article discusses how the pharmaceutical industry can manage the dual demands of advancing drug development while supporting revenue-generating mature products through streamlined regulatory maintenance. By focusing on five key competencies, companies can enhance their management of post-marketing regulatory requirements.

First, operational excellence involves centralizing regulatory operations to ensure strategic oversight and efficient compliance processes. Second, data management through master data solutions and integrated systems improves compliance and reduces errors. Third, regulatory expertise in navigating diverse global requirements and technologies like eCTD ensures effective submissions. Fourth, integrated development across functional teams enhances efficiency and compliance, critical for maintaining supply chain integrity during changes. Fifth, cost control through transparent pricing models and budget forecasting enables informed resource allocation and strategic planning.

Learn more about how these competencies collectively support pharmaceutical firms in optimizing regulatory operations to drive both innovation and sustained revenue streams by downloading the full article below.