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 firstname.lastname@example.org
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
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.