Food
Developing a medical device is hard work. It’s important to protect your time and efforts by developing a regulatory strategy that will allow you to begin marketing and selling your device quickly. I can help you build a regulatory strategy for the US, Europe and other markets. I can also act as your US agent, prepare pre-IDE materials, answer questions about de novo devices and clinical trials. Read More.
Fumbling a 483 or Warning Letter Response or mismanaging a recall or MDR can be an extremely costly misstep. The greatest compliment clients give me is that they should have called sooner. I can help your company respond and protect its customers and its brand. I have experience building SOPs and training staff, managing recalls, and responding to MDRs and import detentions. Read More.
My practice is among the few in the US to focus on food law issues. Colleagues in the food industry cite me as being ”to the top of the field in supporting food producers” with an “outstanding knowledge of the intent, context and substance of the newly enacted Food Safety Modernization Act.” I am familiar with FDA and USDA regulations from imports to food packaging and additives – I am ready to provide smart solutions for your business. Read More.
