Compliance

Compliance is critical.

At best, compliant companies can avoid costly, time-consuming enforcement actions; at the least, compliance helps executives sleep better at night.  HPM helps companies proactively meet federal and state laws regulating their products and activities.

Our attorneys provide companies with the right expertise and perspectives.  We are FDA attorneys – many have worked at FDA, as lawyers and regulators, and know how FDA views compliance.  We have business savvy – many of us have worked within industry and understand the business concerns associated with compliance efforts.  We can help tailor activities relevant to small to mid-sized companies and ensure that complex multi-national organizations remain compliant.

We have written the book (literally) on compliance in all FDA-regulated areas: drugs, biologics, medical devices, foods and dietary supplements, and others. For each of these markets, we advise companies on complying with FDA requirements, from pre-market inspections to post-market registration and listing, advertising and promotion, reporting, and recall activities.  We help companies make decisions to avoid government scrutiny, adverse public reaction, and business disruption.  Let us help you.