We are Life Sciences Consultants serving Class I, II, and III Medical Device companies, Biotechnology companies, and Pharmaceutical companies around the world. MBC & Affiliates, Inc. (MBCA) is a full service Life Sciences consulting firm specializing in Quality Systems and regulatory compliance solutions. Our Life Sciences experts have the real world experience it takes to formulate the right compliance solutions for your unique situation. We partner with our clients to help with everyday needs like managing key suppliers, performing supplier audits, performing internal audits, and being an extra set of hands during high volume business needs. We are also there to help you tackle your most challenging regulatory compliance situations like responding to 483's and Warning Letters and leading cross-functional remediation projects. Continued success in this highly regulated industry is certainly not easy but with knowledgeable medical device consulting partners at your side, your regulatory compliance risks are reduced and your Quality Management System and business performance will positively reflect your commitment. Our model for success: - Long term relationships with our clients - Consistent, practical compliance solutions that work! - Creating high performing Quality Management Systems that support and drive business performance - Reduction of regulatory compliance risk - Improve company's standing with the FDA