Consulting, specialized in the regulation
Eagle Regulatory Consulting LLC is a global strategy consulting firm serving biotech companies, pharmaceuticals, and CROs. Our firm specializes in all regulatory matters, from initial submission to post-market requirements. Whether you’re a developing a new drug or medical device, we will not only realize what you create, but we’ll also help it thrive in the world. We bring extensive experience and knowledge, helping you make decisions that will save time and money.
Get in touch with us to set up a consultation, or email us to enquire whether our services are right for you.
Meet Our Principal
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
Areas of Expertise
Regulation
Navigate the regulatory process efficiently with our extensive experience.
Drug and biologics
We guide your product from submissions and pre-market review to post-market.
Product quality, manufacturing & compliance
Ensure that you meet compliance standards and GMP, and respond to regulatory correspondence and enforcement actions.
Medical device
We help with 513(g), 510(k), PMA, HUD, HDE, IDE, and more.
Business strategy
Get an expert analysis on industry trends, product development, marketing, and promotional practices.
Clinical quality & GCP
Prepare for audits and manage risk with better clinical quality manuals, SOP’s and CAPA.
Contact
☎ Contact
USA: Ying Mu
muying@eagleregulatory.com
Japan: Yumiko Asaka
asakayumiko@eagleregulatory.com