MBCA partners with Life Sciences teams to close the gap between innovation and compliance, turning compliance into a competitive advantage. We combine 35+ years of senior industry expertise, pragmatic regulatory strategy, and the IntelaSolve compliance infrastructure platform to deliver a unified compliance lifecycle backbone that reduces time-to-market, predicts issues before they occur, and de-risks regulatory pathways.
Whether it be Quality Management, Regulatory Affairs, or Clinical advice, MBCA is a global leader and trusted ally for life sciences regulatory compliance. We strive to be the best in the market at what we do. We are consistent in our approach and passionate about the value we provide. We relentlessly build trust and long-term relationships with our clients so they know they can depend on us to deliver and maximize their potential for success.
An effective Quality Management System (QMS) is at the center of all you do. We can help you get it right the first time and sustain it for long term success.
Your regulatory strategy can propel your company forward at the speed of light or can have it stuck in quicksand. Let us help you understand and plan for what’s next.
Clinical protocol design and monitoring can make or break your clearance or approval to market. Get the expert help you need to get it right the first time.
With our vast breadth and depth of knowledge and expertise, we help you navigate the global regulatory landscape, simplify your processes, reduce your regulatory and business risk, and maximize your business performance.
More About UsWhether we are building out the regulatory pathway for your first product, implementing your first quality management system, managing a clinical trial, auditing your suppliers, or helping you navigate a problematic response to a regulator, MBCA provides the experts needed to get the job done with stellar results and within budget. We pride ourselves on being the “go-to” regulatory compliance and Quality System Consulting firm for our clients.
Implementing and maintaining an effective Quality Management System (QMS) is at the center of all you do as a regulated legal manufacturer. Regulators around the globe expect an effective Quality Management System that is compliant with the regulations and standards applicable for your business. Without it, you cannot legally put your product on the US or International market and, if your QMS is not maintained correctly, your products will not stay on the market.
We can help you navigate the complex and confusing regulations and licensing requirements for different countries (US, Canada, EU, Brazil, Australia, Japan, Korea, etc.) and put it all together in an actionable strategy and plan.
We specialize in helping companies with medical devices, diagnostics, biologics, dietary supplements, and combination products take those products from the initial design through the regulatory requirements and ultimately to market.
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"Without a doubt, Melita and her group were the best consultants I have had the pleasure of working with during 30 + years of Medical Device/Combination Products design, manufacturing, sterilization and distribution. I consider Melita to be an expert on Quality Management Systems as well as the Regulations and Standards that govern it. Her auditing resulted in clear and concise opportunities for improvement and her group’s software development/validation/delivery and Service are second to none."
"I have worked with MBCA for seven years and have the highest degree of respect for Melita and her abilities. She possesses a deep knowledge of medical device requirements and the regulatory climate that is not universal among consultants. She understands the intent of the regulations and readily shares this with her clients to teach them and improve their compliance. She not only appreciates the interrelationship of the QMS processes on a philosophical level but has the in-depth of knowledge to translate them into a quality management system that meets your company’s unique needs.
"I have brought MBCA in to work with us on our Quality System on several occasions because I like Melita’s streamlined approach to Quality. She and her team have breadth and depth of experience across a variety of medical device businesses that provides me with confidence that she is keeping us at the forefront of best practice. I recommend MBCA for anyone looking for consulting services in domestic and international Medical Device Quality."
