Meeting the regulatory guidelines set forth by the FDA, ISO and other regulatory authorities is a huge challenge for life sciences companies. While enterprise quality management software (EQMS) can put your organization on the path to regulatory success, even the most advanced technology will be compromised by poor quality processes. MasterControl Quality and Compliance Consulting (QCC) offers a variety of regulatory assessment, consulting and training services that help medical device companies, drug makers, and other regulated manufacturers resolve their most critical quality management issues and optimize their companywide compliance operations.
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MasterControl QCC offers a host of quality assessments and consulting services to help you identify the strengths and weaknesses of your current quality processes, or any component related to improving the compliance of those processes. If your organization is experiencing "death by CAPA," difficulty resolving FDA 483s and other complex nonconformances, recurring issues due to poor root cause identification, or simply a lack of confidence in the knowledge or decisions of the quality team, we can help you resolve these issues and satisfy your industry-specific regulatory challenges, including guidance on GxP, ICH or other global best practices. As a result, you will enjoy reduced costs and compliance headaches, faster time to market and increased productivity.
MasterControl QCC provides industry expertise in seven core regulatory, compliance and quality disciplines:
Instead of a cookie-cutter approach, MasterControl QCC will assess your company's unique needs to help you develop a quality management system (QMS) that will satisfy your specific regulatory challenges and business objectives. Whether you're looking for limited training to improve a specific quality process, such as CAPA event management, or comprehensive help to design and implement a closed-loop quality system that is compliant with regulations from FDA and other international regulatory bodies, QCC can help you make sense of global compliance and how it impacts your business processes.
Our consultants understand the unique demands of regulated companies. Having developed, implemented and managed quality systems that comply with U.S. (FDA), UK (MHRA) and EU (EMA) regulations, as well as international standards (ISO) and guidelines (ICH), our consultants have experience with hundreds of drug and device products and categories in countries all over the globe. This, coupled with our unique technical expertise, enables us to provide complete quality management and compliance solutions. Partner with QCC, and you will be able to enter new markets quickly and cost-effectively, without having to hire multiple consulting firms or entrust your product registrations to unaffiliated consulting partners.
For more information about MasterControl QCC's regulatory assessment, consulting and training services, contact us today at +1 (866) 747-8767.