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
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.
At FDAMap
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.