US Representative Services

Your designed US representative to the FDA should be intimately familiar with local regulatory guidance and equipped to both guide you through the process and act on your behalf. 

Kapstone’s regulatory experts are available to fill that role for your team. We pride ourselves on our up-to-date regulatory expertise and have a proven track record of advocacy in the competitive, challenging US market. 

Assigning an FDA Official Correspondent (OC)

Your business will also need to appoint an official correspondent (OC) to the FDA. Your OC will be responsible for:

• Annual registration of your business and listing of its activities with the FDA, including maintenance of existing registrations and listings
• Adding your business to previous listings, if it takes on new responsibility
• Maintaining current personnel lists for all assigned businesses
• Receiving and responding to FDA correspondence relevant to business activities, registration, and listing

You can appoint the same person or team to serve as both your US representative and OC. Kapstone regulatory experts often take on both roles for our clients.