As a Principal Consultant at ChemPharm, I specialize in regulatory compliance for pharmaceuticals and medical devices. My expertise covers USFDA, CFDA, PIC/s, EU GMP, GxP, and ISO standards. I lead a consultant team working on GMP/GLP/GDP/GVP projects in mainland China, Hong Kong, Taiwan, India, Australia, New Zealand, and ASEAN countries. Responsibilities include ensuring regulatory adherence, quality assurance, risk assessment, compliance auditing, and gap analysis. I also manage regulatory affairs, provide GxP training, oversee analytical testing, and enhance process capabilities. My deep understanding of ISO13485 and 21 CFR Part 820 compliance is particularly valuable in the medical device sector.