U.S. FDA Team

Welcome to our esteemed FDA regulatory consultant team, where expertise converges with innovation to navigate the complex landscape of regulatory and clinical compliance. Comprising seasoned professionals with a unique blend of deep functional expertise, our team stands at the forefront of ensuring that your products meet the standards of safety, efficacy, and quality. With a deep understanding of the evolving regulatory environment, our consultants bring a comprehensive perspective to guide you through the FDA approval, from product development to market approval.

• 20+ years of experience for principal consultants, 10+ years of experience for team members
• 500+ successful launch for medical device, SaMD, IVD, CDx and combination products.
• Our IVD principal consultant has over 25 years of experience in medical device and in vitro diagnostic (IVD) regulatory affairs, quality assurance, research and development, and clinical affairs. Worked as Director/Head of IVD regulatory department for multi-billion multinational companies.
• Our active device/software principal consultant is a highly accomplished medical device executive with 20+ years of experience. Held a long track record of developing world-class regulatory organizations, advocating on regulatory policies, formulating innovative regulatory strategies, and successfully navigating dynamic global medical device regulatory processes. Product experiences cover medical devices of all risk classifications (Classes III, II and I), as well as general health and wellness products.
• R.A.C certified team members