Compliance Infrastructure for Life Sciences Innovation

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.

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Services

Turning Compliance Into Performance With Confidence, Certainty & Control

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.

Quality Management

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.

Regulatory Affairs

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 Research

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.

MBC & Affiliates quality systems consultants

Who we are

Gain Access to Regulatory & Quality Experts That Execute

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.

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Comprehensive services

Full Service Quality System & Regulatory Consulting Firm

Whether 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.

Quality Management Systems
IntelaSolve eQMS
QMS Remediation
Internal Audits
Training & Education
FDA 483, Warning Letter, Consent Decree
Supplier Qualifications and Audits
Mergers & Acquisitions Due Diligence

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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.

Global Regulatory Strategy and Registration
Country-Specific Regulatory & Commercialization Plans
U.S. Product Classifications & FDA meetings (Pre-sub meetings, 513(g) filings)
U.S. Regulatory Submissions: 510(k), De Novo, PMA
Interim Regulatory Professionals
Regulatory Due Diligence

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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.

Clinical Research & Protocol Design
Clinical Trial Monitoring
Clinical Trial Audits
Medical Writing
GCP Training
Institutional Review Board / Ethics Committee Negotiations
Selection of Clinical Research Organizations
Clinical Project Schedules and Budgets

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Medical device quality management systems

Client stories

Featured Client Success Story

I had the pleasure of working with MBCA to prepare staff for an imminent FDA inspection. Melita was extremely knowledgeable and a superb coach. I continue to recommend Melita and her firm to both life sciences companies and to colleagues with world class regulatory and compliance skill sets.

Eric Henry, Sr. Quality & Regulatory, Boston Scientific

I worked with MBCA on Pre-FDA audit prep activities/Mock Audit and in-house training. Melita provided the opportunity for first time SMEs to have an FDA prep- "hats on/hats off" auditing practice. Excellent support by Melita. Engaging, supportive and a great coach. Listened to our requirements carefully and delivered. She helped grow confidence/understanding in a real and practical way for SMEs. Result: Successful audit experience. Wrapped up one day early. ‍ Melita also ran in-house training to a targeted team on Medical Device Quality Auditor training covering Quality System auditing, audit phases & activities, tips & techniques, key auditing elements on QSIT GUIDE, 21 CFR Parts 803, 806, 820 & 11, Medical Device Directive (MDD), Canadian Medical Device Regulations (SOR/98-282), Brazil Ordinance RDC No. 16/2013, MHLW Ordinances 1 & 169, and ISO 13485. The course materials, case studies, and final assessment were all included. It was a good pace, and all team members gave very positive feedback on the 4.5-day course. Overall Melita attended to our requirements in a positive and very supportive manner. She was available to answer queries remotely if required. Good support, much appreciated. She listened and responded to her customer requirements, certainly helping to make our quality team increasingly effective for our business. ‍

Sara Cahill, VP, Head of Quality

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." ‍

Kevin O'Reilly, Regulatory Compliance and Standards at Siemens Healthineers

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