Our Services

FDA Compliance Audits and Services

FDAMap experts have successfully conducted over 100 GCP, GLP, GMP, and GACP audits 

For inquiries on FDAMap services, please contact call  at 410-501-5777 or write to info@fdamap.com

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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 audits at their premises.

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


We have Extensive Experience​

The regulatory affairs team at FDAMap has 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:

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

Regulatory Services | FDA Auditing | Clinical Trial Services

FDAMap provides a comprehensive range of FDA services to companies regulated by the US FDA, EMA, and similar agencies.