Partnering in advancing public health and patient care
Your institution is dedicated to the service of the public good – from caring for the sick to conducting cutting edge research. Compliance with FDA and DEA laws and regulations can seem a daunting addition to, and distraction from, your mission. HPM can be an effective partner to assist and guide you in advancing public health and patient care, as well as developing regulatory strategies for bringing your advances to the broader public.
Our attorneys spend their careers considering and finding solutions to these issues. We’ve helped individual professors bring an idea through the FDA to the clinic and we’ve helped entire health care systems develop pragmatic and efficient systems designed to ensure compliance with FDA and DEA requirements.
Let us help you help the world – one patient and one idea at a time
Specifically, we can help you:
- Develop a regulatory strategy that maximizes your chance of success
- Open investigational authorizations (INDs, IDEs, INADs)
- Prepare for meetings with FDA
- Organize and submit your data to FDA
- Design clinical studies that demonstrate product safety and efficacy and that will create efficiencies in the later FDA review and approval process
- Seek FDA approval for emergency and/or compassionate use of a product that you believe is necessary for your patient
- Advise on FDA and import issues related to medical devices
- In matters related to controlled substances
– advocate for appropriate drug scheduling and licensing
– advise on quota issues related to production and imports
– ensure effective security, record keeping and reporting