FDAMap provides a comprehensive range of quality assurance and regulatory GxP compliance services to the pharmaceutical, medical device, biotechnology, dietary supplement, and other FDA-regulated industries in the United States and other countries of Europe, South America, and Asia. We help develop a right-sized quality assurance program and implement a Quality Management System (QMS) that complies with FDA’s Quality System Regulation (QSR).

Our quality assurance experts can help you if you have an upcoming FDA audit at your manufacturing facility to ensure you are fully compliant with FDA guidelines. In case, you want to run a mock FDA audit or gap analysis, we completely ensure your system and records are FDA acceptable and compliant in all aspects. We have 200 corporate quality system audits to our credits in the US and other countries. We assist you in the creation and review of standard operating procedures (SOPs) and quality issues management.

We help you identify the grey areas of your controlled processes throughout all phases of pharmaceutical drug development and pharmaceutical manufacturing to drive new efficiencies and to promote transparency. Our professional experts provide a comprehensive QA framework, quality assurance assistance, and quality oversight to help you meet the regulatory requirements. In order to ensure compliant products are delivered to your company/facility, your critical suppliers must be audited since you cannot ignore the risk associated with your suppliers notwithstanding they are FDA registered, ISO certified, or engaged with some large international drug or medical device companies.