Pioneering healthcare regulatory excellence for over 15 years
At Naya Rai, we empower healthcare innovators to navigate the complex regulatory landscape with confidence. Our mission is to accelerate the delivery of life-changing medical products to patients worldwide through strategic regulatory guidance and unwavering compliance excellence.
We believe that regulatory expertise should be a catalyst for innovation, not a barrier. By combining deep technical knowledge with creative problem-solving, we transform regulatory challenges into competitive advantages.
Certified and Recognized By
The principles that guide every decision we make
Meticulous attention to regulatory details ensuring submission accuracy
Cutting-edge strategies for novel and complex healthcare products
Collaborative approach treating your success as our own
Deep knowledge of regulatory frameworks across all major markets
Uncompromising quality standards in everything we deliver
Track record of accelerating market access and approval success
Founded in 2011 by a team of former regulatory agency officials and industry veterans, Naya Rai was born from a simple observation: brilliant healthcare innovations were being delayed or denied not because of scientific merit, but due to navigational challenges in the regulatory process.
What started as a boutique consultancy has grown into a global regulatory powerhouse, serving clients from cutting-edge biotech startups to Fortune 500 pharmaceutical companies. Our success is measured not just in approvals, but in lives improved through faster access to innovative healthcare solutions.
Today, with offices on five continents and a network spanning over 25 countries, we maintain the personalized attention of our early days while delivering the expertise and resources of a major consultancy.
Meet the experts driving regulatory excellence worldwide
Chief Executive Officer
Former FDA official with 20+ years in medical device regulation and global healthcare policy. Pioneering innovative compliance strategies.
VP of Global Affairs
Expert in international regulatory harmonization across 25+ countries
James Liu
Regional Director - APAC
Emma Schmidt
Regional Director - EMEA
Carlos Mendes
Regional Director - LATAM
VP of Clinical & Scientific Affairs
Pioneering clinical trial design for breakthrough therapies and novel devices
Dr. Alex Kumar
Clinical Strategy Lead
Dr. Rachel Green
Scientific Affairs Lead
VP of Quality & Compliance
ISO 13485 expert ensuring world-class quality management systems
Lisa Anderson
Quality Systems Manager
David Park
Compliance Manager
Sophie Chen
Audit Lead
VP of Operations
Streamlining regulatory processes with innovative project management
Robert Kim
Project Management Lead
Nina Patel
Operations Manager