About Us
At Global FDA Partners, we guide innovators through the complex FDA regulatory landscape with clarity, confidence, and precision. We support emerging and established brands in bringing safe, compliant, and trusted products to market.
From product classification to regulatory submissions and documentation support, we transform a complicated approval process into a clear, structured pathway — helping clients avoid costly delays, compliance risks, and unnecessary stress.
We believe compliance shouldn’t be a barrier to innovation. It should empower it.
Our Mission
To provide accessible, expert FDA regulatory support that accelerates innovation, protects consumers, and builds trust between brands and the market — without the overwhelm or confusion traditionally associated with compliance.
We exist to give companies the knowledge, structure, and confidence they need to succeed in highly regulated industries.
Our Approach
We combine regulatory expertise with a personalized, human-centered approach. Every product, founder, and pathway is unique — and so is our guidance.
Our process is built on:
- Strategic evaluation of regulatory pathways
- Clear communication and expectation setting
- Step-by-step structured guidance
- Efficient documentation & submission support
- Proactive compliance strategy to prevent future issues
No guesswork. No generic advice.
Just clear steps, expert support, and partnership from start to finish.
Why Choose Us?
- Boutique, high-touch support — not cookie-cutter solutions
- Specialized experience with emerging & fast-growing brands
- Fast turnaround & responsive communication
- Clear deliverables, transparent process, and no regulatory guesswork
- Support tailored to product category, business stage, and launch goals
Whether you’re preparing a first-time submission or optimizing compliance for scale, we provide structured expertise that saves time, money, and stress.
Leadership
Yen Chun Chen — Founder
Yen Chun Chen brings extensive experience in client-focused service industries, where she developed a strong foundation in process management, quality assurance, and customer experience delivery. With a proven ability to support and guide clients through complex workflows, she brings a meticulous, service-driven perspective to regulatory consulting. Her background in high-touch service environments has equipped her with exceptional communication, organization, and problem-solving skills — enabling her to provide reliable, structured, and client-centered support throughout the compliance and submission process. She is committed to making regulatory navigation clear, efficient, and accessible for brands of all sizes.
Evelyn Chao — Co-Founder & Lead Regulatory Consultant
Evelyn Chao brings a background in healthcare innovation, FDA regulatory systems, and scientific research, with hands-on experience supporting product approval, clinical environments, and compliance strategy. She co-founded Global FDA partners to bridge the gap between traditional regulatory systems and modern entrepreneurs — helping companies navigate FDA expectations with confidence, accuracy, and clarity. Evelyn is committed to making compliance approachable and empowering, especially for founders and early-stage innovators who are building products that improve lives.
