Marylène Zhan

Founder of PV Solutions Limited

Ms. Marylène Zhan has over 10 years of experience in pharmacovigilance (PV) and regulatory affairs (RA), with extensive expertise in supporting international pharmaceutical companies entering and operating in the Chinese market. She holds a Master’s degree from Zhongnan University of Economics and Law.

As a bilingual and bicultural regulatory consultant, Marylène specialises in China regulatory compliance and pharmacovigilance services. She possesses in-depth knowledge of China’s pharmaceutical regulatory framework and extensive experience navigating complex market access and compliance requirements.

Throughout her career, Marylène has successfully supported multinational pharmaceutical and biotechnology companies in achieving regulatory compliance in China. Her areas of expertise include GCP and GVP audits, Chinese GVP implementation and compliance, pharmacovigilance system establishment and optimisation, SOP development and quality management systems, regulatory intelligence, inspection readiness, and strategic regulatory consulting. She is committed to helping global organisations build compliant, efficient, and sustainable pharmacovigilance systems that meet China’s evolving regulatory expectations.