Bridging Innovation and Regulation: How BaysMartin Consulting Guides Biotech and Pharma Firms Through Complex Approvals

In a field where innovation meets regulation, Carol Houston, founder of BaysMartin Consulting, understands the delicate balance between them. With over 25 years of experience in regulatory, quality, and clinical affairs, Houston has established a consulting firm that assists companies in navigating the complex world of biotech, pharmaceuticals, healthcare laboratories, and medical devices.

“I have always seen my role as that bridge between innovation and compliance,” Houston explains. “When a company develops a product, whether it’s a medical device or a diagnostic tool, they need someone who can help them understand what the regulators are looking for and how to demonstrate safety and effectiveness.”

Founded six years ago, BaysMartin Consulting operates within the life sciences sector, supporting clients at various stages of product development. Many of those clients are organizations developing regulated products that require approval from federal or international agencies before entering the market. Houston’s firm assists them through that process, from preparing documentation and risk assessments to helping teams understand evolving regulatory expectations.

Her work often begins at the earliest stage of product design and continues through to final submission. In some cases, BaysMartin Consulting is brought in later, particularly when companies face challenges such as recalls or compliance findings. “Sometimes I’m helping clients get their product to market,” Houston says. “Other times, I’m helping them understand what went wrong and how to address it responsibly.”

Houston possesses a blend of scientific, business, and legal insight. She holds multiple advanced degrees, including an MBA, a Master’s in Bioscience RA, and a Master’s in Health Law. She’s now pursuing a doctorate in pharmaceutical studies. Houston is also a board-certified clinical laboratory scientist with a background in histology, a technical foundation that deepens her understanding of the scientific details behind every product she helps guide.

“I call that my advantage,” she says. “You hardly find someone who understands the science, the regulations, and the business strategy altogether. It gives me perspective from every side of the table.”

Her experience extends beyond U.S. borders. Houston has worked with companies across Europe, the Middle East, Africa, and Central America, helping them align with both domestic and international requirements for product approval. This global perspective has proven increasingly valuable as regulatory expectations evolve worldwide.

BaysMartin Consulting is also federally certified as a woman-owned small business, registered with the Small Business Administration. This certification enables the firm to participate in various partnerships and projects. “That federal certification process is rigorous,” Houston says. “It’s designed to ensure that companies like ours are both qualified and credible.”

In addition to consulting, Houston is applying her decades of experience to develop an AI-powered product designed to enhance laboratory workflow efficiency. The technology, developed under her company’s umbrella, is currently in early-stage validation and seeking seed funding.

“The goal is to streamline how laboratory tests move from collection to result,” she says. “Most people don’t realize how many steps are involved in that process. Our technology is designed to make that journey smoother and faster, which could have a real impact on patient experience.”

The AI project represents the foundation for a broader vision. Houston is also planning to establish a physical laboratory that will serve as both a research and development space and a testing site for her new technology. Being one of the few African American women biotech founders in this industry, she takes pride in her accomplishments. “I have always believed that innovation happens when you combine practical experience with forward thinking,” she says. “The lab will give us a place to bring those ideas to life.”

Although the work is complex and challenging, Houston is motivated by the desire to create a lasting legacy. “I have spent my career helping others bring their ideas to market,” she says. Through BaysMartin Consulting, Houston continues to guide life sciences companies toward responsible innovation, ensuring progress is safe, effective, and aligned with strong ethical standards.