About
Specialized Consulting in FDA Biologics and Small Molecule Regulations
At Shining Data LLC, we are dedicated to delivering expert regulatory solutions that simplify FDA compliance for biologics and small molecules. Our mission is to empower clients with clear, cost-effective strategies grounded in over two decades of industry experience and insider FDA insights, ensuring their products reach market safely and efficiently.
Expert Regulatory Guidance for Biologics and Small Molecules
Meet our ex-FDA experts dedicated to streamlining your path to market.
Laura Simmons
Regulatory Strategy Lead
With over two decades in FDA biologics, she ensures tailored, efficient regulatory pathways.
David Chen
Senior Regulatory Consultant
David leverages deep biosimilar expertise to anticipate and solve complex regulatory challenges.
Anita Patel
Technical Compliance Manager
Anita drives innovation with her strong background in small molecule product development.
Michael Nguyen
Director of Regulatory Affairs
Michael leads with insight and strategic acumen to navigate FDA requirements efficiently.
Trusted Advisors in FDA Biologics and Small Molecule Solutions
Hear directly from our clients about how Shining Data LLC’s expertise helped them successfully navigate complex FDA regulatory pathways.
“The team’s deep regulatory knowledge and strategic guidance were invaluable in accelerating our product’s FDA approval process. Highly recommend!”
Dr. Emily Saunders
Regulatory Affairs Director
“Professional, insightful, and efficient – Shining Data’s team consistently delivered exceptional regulatory solutions tailored to our needs.”
Michael Chen
Senior Biologics Consultant
“Their expertise made navigating FDA requirements straightforward, allowing us to focus on innovation and product development with confidence.”
Sarah Patel
Head of Regulatory Operations