Managing Post-Market Regulatory Demands At The Local Affiliate Level

By Dr. Stefanie Lietsch-Dallwig, Senior Director Global Program Management, PharmaLex

Globalization presents both opportunities and challenges for the pharmaceutical industry. Companies must navigate diverse regulatory landscapes, ensuring compliance while maintaining product quality. Despite efforts to harmonize regulations, significant differences persist across regions, including within the EU, where specific country requirements exist, such as France's mandate for a local pharmaceutical establishment. Local affiliates are tasked with meeting these requirements, but often struggle to align with corporate strategies due to resource limitations.

To enhance efficiency, many companies consider outsourcing regulatory tasks, allowing them to focus on strategic initiatives. Additionally, hiring qualified professionals in competitive markets poses challenges, making partnerships with expert service providers a sustainable solution to meet compliance needs and streamline operations.