FDA Audit Services You Can Trust

Ensure FDA Compliance with Confidence

At FDAMap, we specialize in providing comprehensive FDA audit services to help your organization stay fully compliant with regulatory standards. With a proven track record of conducting over 100 successful GCP, GLP, GMP, and GACP audits across the United States, Europe, South America, and Asia, we are the trusted partner for companies manufacturing drugs, medical devices, biologics, foods, cosmetics, and supplements.

Our team of experienced auditors not only conducts thorough evaluations but also prepares your organization for real FDA inspections. We offer mock FDA audits on-site to identify gaps and strengthen your readiness. Whether you are a small startup or an established manufacturer, our expertise ensures that you face FDA audits with confidence and competence.

Comprehensive FDA Audit Support

Our FDA audit services cover all critical areas of compliance:

• Conducting audits to assess adherence to FDA regulatory standards.

• Developing Standard Operating Procedures (SOPs) for GMP, GCP, and GLP compliance.

• Vendor certification audits to ensure your suppliers and partners meet FDA expectations.

• Training programs in GMP, Quality Assurance (QA), and Quality Control (QC) to keep your team audit-ready.

• Support in drafting responses to FDA warning letters and observations.

• Direct liaison with the FDA during the inspection and response processes.

• Monitoring Adverse Event Reporting and ensuring Drug or Device Accountability.

• Managing Protocol Violations and Waivers with full regulatory documentation.

• Oversight of Clinical Investigators, IRBs, Sponsors, and CRO communications.

• Reviewing Laboratory Data Collection processes for integrity and compliance.

• Managing Financial Disclosure Requirements critical for clinical trials.

Why Choose FDAMap?

• Global Experience: Successful audits in multiple countries across three continents.

• End-to-End Support: From audit preparation to post-audit liaison with the FDA.

• Customized Training: Hands-on workshops tailored to your operations.

• Mock Inspections: Realistic practice to ensure audit success.

• Expert Team: Auditors with deep knowledge of FDA regulatory frameworks.

Stay a step ahead of FDA inspections.

Contact FDAMap today to schedule your audit consultation and protect your business with expert regulatory support.

To speak to our FDA audit expert, please call +1 410-501-5777 or email: info@fdamap.com.