Who We Are

Heather helps companies succeed by reviewing their products for compliance with FDA, FTC and CBP regulations. She also has a background as a former corporate general counsel, which rounds out her ability to assist companies ranging from startups to Fortune 500. Heather has a proven ability to think creatively about business strategies for compliance and makes the process easy to understand.

With 19 years of experience in office and operations management, Ali is a natural problem solver who creates structured, supportive approaches that enable clients to connect, be visible, scale, and grow. She specializes in project management systems, developing business hubs, mapping the client journey, process improvement, systems and automation, outsourcing strategy, and customer experience. Systems Strategist and Online Business Managerhelps small businesses enhance their customer experience and bottom line through customized strategies, implementation, and training in project management systems, processes, and productivity tools.

David is a dedicated food safety expert with over 11 years of experience helping businesses achieve their food safety goals. His passion lies in collaborating with clients to create tailored solutions that address their unique needs and challenges. With a proven track record of success, David has guided over 70 food industry clients through GFSI certification processes. He understands the intricacies of food systems and brings a practical, business-oriented approach to every project.

Dorene Markwiese is a seasoned FDA compliance consultant with extensive expertise in regulatory submissions, compliance management, and leadership within the medical device industry. Her experience spans 510(k) and PMA submissions, and CE Mark submissions, along with guiding clients through complex global regulatory landscapes.

Dorene has successfully directed responses to FDA Warning Letters, managed FDA recalls, and played a key role in achieving ISO 9001 certification. She has also led regulatory efforts in CAPA coordination and established robust systems to track regulatory impacts. With strong leadership skills, she excels in project management, strategic communication, and mentoring teams.

Lisa Capote practices FDA, FTC and CBP compliance among others and has a passion for assisting businesses succeed. She is an AV Preeminent-Rated attorney, which is the highest level of professional excellence ranking. Ms. Capote represents various clients from Fortune 500 to startup companies in international trade.

Chris Bustos is the Director of Operations at Bustos Law Group, where he drives the firm's growth and enhances customer service through operational management and strategic use of technology. With over a decade of experience, Chris excels in process optimization, strategic planning, and team development, ensuring seamless service delivery and an exceptional client experience. His innovative approach and SHRM certification make him adept at fostering a supportive, high-performing work environment. Chris's expertise bridges the gap between strategic objectives and operational realities, propelling Bustos Law Group to new heights.

Ketki brings wide-ranging experience of over 18 years in the food industry, from the microbiology of safe food preservation to the exploration of new food markets to legal compliance issues within international trade. She has consulted and trained many small and large size companies in FSMA and other International regulations. She interacts with the FDA and other International regulatory bodies on regular basis. Ketki has completed my Food Technology and Bachelor of laws and Master of Laws in Food and Agriculture Law from Vermont Law School. During her LLM program she interned with Texas State Department of Health Services in Food safety and consumer protection division and was trained with FDA on various compliance and investigation programs. She is FSPCA lead instructor for FSMA Preventive controls and Foreign supplier verification program (FSVP) and HACCP trainer.

Kerry Tassopoulos is a seasoned attorney with over 35 years of experience in Texas, specializing in helping businesses navigate legal and regulatory challenges. He spent 25 years at Mary Kay Inc., advising on global regulatory and distribution issues and serving in leadership roles across public affairs, risk management, and more. Kerry has also held significant positions at Jani-King International and Excel Communications, gaining expertise in FDA and FTC regulations related to franchising, direct sales, and advertising.

Harold is a former FDA compliance officer with over 20 years of experience who has worked with companies to obtain and maintain FDA compliance in many regulated industries. He is currently the principal of Reg-e-stration, a company specializing in FDA registration services and consulting. He brings years of experience and a wealth of knowledge to the BLG team.

Dr. Simone Swafford is the CEO and Founder of Vogue Regulatory, LLC. Before establishing Vogue Regulatory, Dr. Swafford worked for small to large-sized companies in the beauty, personal care, consumer healthcare and dietary supplement industries, and has over 18 years of experience in U.S. and international regulations. She earned both her master’s degree and the only one of its kind, doctorate in Regulatory Science from the University of Southern California. Dr. Swafford has given the cosmetics lecture in the Introduction to Medical Product Regulations course at USC and has also written the Cosmetics chapter in the USC regulatory textbook, “An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco”.