Regulatory QMS & Audit Support
Regulatory Quality Management System (QMS) and Audit Support refers to the processes, systems, and tools used by organizations to manage their regulatory compliance with relevant quality and regulatory standards. This includes quality management systems such as ISO 9001, as well as industry-specific regulatory requirements. The goal of a Regulatory QMS is to ensure that an organization’s products and services meet regulatory requirements, and that its processes and systems are in compliance with relevant quality and regulatory standards.
Regulatory Audit Support involves providing assistance to organizations during regulatory audits, which are conducted by regulatory authorities to assess an organization’s compliance with relevant regulations. This can include preparing for an audit, responding to audit findings, and implementing corrective actions to address non-compliance issues. The goal of Regulatory Audit Support is to help organizations pass regulatory audits and maintain compliance with relevant regulations.
By implementing a Regulatory QMS and receiving regulatory audit support, organizations can ensure that their products and services meet regulatory requirements, reduce the risk of non-compliance and fines, and improve their overall regulatory performance.
Establishing and Optimizing Your Regulatory QMS
By setting up a robust Regulatory QMS, we can help your organizations to ensure that your business processes and systems are in compliance with relevant quality and regulatory standards, eliminate non-compliance risks, and improve your overall regulatory operations. Our team can provide expert guidance and support in navigating the complex and ever-changing regulatory landscape with the following services:
QMS Implementation & Process Optimization
Implementing a regulatory quality management system (QMS) to meet relevant quality and regulatory standards, such as ISO 9001, ISO 13485, etc.
Regulatory Compliance Assessments
Conducting assessments of your organization’s processes, systems, and products to identify areas of non-compliance and recommend corrective actions.
Regulatory Gap Analysis
Evaluating your organization’s current processes and systems to identify gaps in regulatory compliance, and recommending corrective actions.
Regulatory Document Management
Developing and maintaining an effective system for managing regulatory documents, such as policies, procedures, and submissions.
Regulatory Audit Preparation and Support
Assisting your organization in preparing for regulatory audits, responding to audit findings, and implementing corrective actions to address non-compliance issues.
Monitoring and Reporting
Monitoring regulatory developments and changes, and providing regular reports to your team members to help them stay up-to-date and maintain compliance.
Our Regulatory QMS & Audit Support Services
With over 15+ years experience, our regulatory team has helped several pharma and medical device companies to prepare and stay ready for the following types of audits: