Professional Services


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            FDA Compliance Audits and Services

FDAMap experts have successfully conducted over 100 GCP, GLP, GMP and GACP audits for drugs, medical devices, biologics, foods, cosmetics and supplements in the US and several countries in Europe, South America and Asia. We help train drug and device manufacturers in FDA audit preparation and conduct mock FDA audit at their premises.

Our regulatory experts have been involved in more than 100 multi-national clinical trials, has made hundreds of submissions to the US FDA, EMA, and regulators in more than 20 countries. We have created and led numerous teams for development of pharmaceutical, biotech and medical device products all the way from early stage development to commercial markets.

The regulatory affairs team at FDAMap have extensive experience obtaining United States Food and Drug Administration (FDA) approval of manufacturing and distribution sites of drugs, medical devices and food supplements in the United States and several other countries.

Our auditing services cover following areas:
  • Performing audits to evaluate compliance with regulatory standards
  • Preparing standard operating procedures (SOP) for Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) compliance
  • Providing vendor certification
  • Conducting training in GMP, quality assurance, and quality control
  • Assisting in the preparation of responses to warning letters
  • Liaising with the FDA
  • Adverse Event Reporting
  • Drug or Device Accountability
  • Protocol Violations and Waivers
  • Clinical Investigator Oversight
  • IRB, Sponsor and CRO Communication
  • Laboratory Data Collection Process
  • Financial Disclosure Requirements
​Inquiry Form:
+1 410-501-5777
+1 877-566-4981