About Regulatory Options

Regulatory Options is a consulting firm that assists FDA-regulated companies in achieving business success. Our vision is for our clients to have the best products, which are in compliance with applicable laws and industry regulations.

Our unique experience in production and quality challenges the consultant status quo and provides real options helping you to operate efficiently and cost-effectively in this highly regulated environment.

Here is a statement from Regulatory Options’ Founder Brandon Lesniak:

“I’ve enjoyed working with people and figuring out puzzles all of my life. Becoming a consultant has allowed me to bring together these two passions. Over the years I have worked with a wide variety of manufacturers, large and small. I have a diverse knowledge gained in troubleshooting industry problems and performing audits of a wide range of manufacturers. Before becoming a consultant, I worked at spray drying, powder blending, soft-gel encapsulation, oil pressing, emulsifying, liquid processing, fermentation, and agricultural companies. I directed teams to obtain numerous certifications such as NSF, NSF Certified for Sport, Informed Choice, Non-GMO, GFCO, and USDA Organic. As well as the application of and maintenance of USDA Veterinary Biological Products and NSF Certified for Sport Products. I am an active member of numerous professional and scientific organizations. I am a graduate of Western Washington University in Bellingham, Wa.”