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 Training
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.
Continuous improvement
Supporting your organization in continuously improving your regulatory compliance processes and systems, and in achieving your regulatory goals.
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:
- Ensuring accuracy and completeness of information
- Drafting content as per latest regulatory guidelines
- Effectively communicating complex information
- Applying latest methods in scientific research
- Leveraging latest technology for content creation
- Always meeting timelines and avoiding delays
Your Questions & Our Answers
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.
