We recognize that your business might be affected by FDA requirements even though you do not market FDA-regulated products. For example, we advise:
- Cosmetic ingredient developers and manufacturers
- IRBs and clinical investigators doing clinical trials for manufacturers on how to manage facilities and records inspections carried out under FDA's Bio-Research Monitoring Program
- Mammography radiology facilities on FDA inspections
- Hospital biomedical research facilities that modify existing products on their FDA liability
- Professional societies on the problems related to having society meetings and activities funded by manufacturers
Additionally, we assist you by providing expert testimony in private litigation on FDA regulations, and by reviewing and advising on FDA compliance issues affecting your business transactions and financial documents.