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 use the contact form at the bottom of this page to enquire whether our services are right for you.
Contact
☎ CONTACT
USA: Ying Mu muying@eagleregulatory.com
Japan: Yumiko Asaka asakayumiko@eagleregulatory.com
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.
“Regulation needs to catch up with innovation.”
Let's Chat.
Use the form below to contact us regarding your enquiry. Please be as detailed as possible. Include your industry along with any specific requests. You may also email or call us to make an appointment.