Quality Management, Quality Assurance, & Inspection Readiness

SWOT Quality Specialists can help ensure you have everything you need to guarantee quality standards are met within your company, including writing and/or editing Standard Operating Procedures (SOPs), Policies, Work Instructions, Business Processes, and Corrective Action Planning & Response documentation. We specialize in creating real-world documentation based on your company's actual capabilities and processes while adhering to regional guidance and regulations.

A successful trial or drug application starts with your data and the operational systems in place to capture it. SWOT Quality Specialists are equipped to audit your quality systems and Trial Master Files to ensure your systems meet regional guidance and regulatory requirements and set you up for success with agency submissions.

Being prepared for an agency inspection is vital to ensuring there are no avoidable delays in your pipeline. SWOT Quality Specialists can analyze your state of readiness and help you develop an Inspection Readiness Plan. We can also help you execute the plan so that you're ready when the FDA or any other agency knocks at your door.