History
Eagle Regulatory Consulting was formed in September 2017, when Dr. Ying Mu, after nine years of working at the FDA, realized that there was a large demand in industry to streamline products through regulatory pathways. Too often, drugs and medical devices get mired in the review process and may not get to market. We work tirelessly to reverse this trend. Our passion is to facilitate the success of our clients and help them achieve their goals.
Team
principal
Ying Mu, PhD, DABT
Dr. Ying Mu holds a PhD in medicine (Japan), a board-certificate of toxicology (D.A.B.T.) and is a former FDA officer. He has accumulated over 25 years of research in the life sciences, specializing in biomarkers, toxicology, pharmacology, oncology, and animal testing. He has published thirty peer-reviewed scientific articles with over 1000 citations. From his work in the FDA in CDER (drugs) and CDRH (medical devices), he possesses a unique expertise in navigating clients through the regulatory pathways.
Languages
• English, Chinese (Mandarin), Japanese
Partner
Joseph Junhai Ou, MD, MSc, CCRP
Dr. Jospeh Junhai Ou has passed the US Medical Licensure Exams, and holds a SoCRA clinical research certificate. In his over 30 years of experience in pharmaceutical and clinical research, he was PI or co-PI in numerous clinical studies following GCP, ICH, HIPPA and FDA regulations. As Scientific Manager of Clinical R&D, he was responsible for coordinating clinical monitoring and safety reviews in national and international studies. He has published over forty research papers in peer-reviewed journals.
Languages
• English, Chinese (Mandarin)
Partner
Yanzhuo Wu, PhD
Dr. Wu has fifteen years of experience in PI, director, and VP positions in the pharmaceutical industry, and his experience focuses mainly on preclinical R&D and premarket readiness. He has in-depth knowledge of regulatory pathways in China, including regulation, guidance, standards, and compliance, and has led several INDs and NDAs to CFDA approval. Currently, he is an expert consultant at ERC and serves as CEO of Beijing Ding Feng Pharmaceutical Technology Co., Ltd.
Languages
• English, Chinese (Mandarin)