US representation
Medical Devices and Pharma represents foreign device and pharmaceutical manufacturers as an intermediary between the company and FDA. This important service facilitates communication between the manufacturer and FDA and helps to ensure compliance with US regulations.
The U.S. agent is responsible for establishing and maintaining records and performing regulatory reporting as required. The agent maintains confidentiality of sensitive information and adheres to relevant laws and regulations governing medical devices and FDA interactions.
Depending on the contractual details of the company-agent relationship, the agent may also file updates for annual establishment and product registrations, assist with the filing of product marketing submissions, and assist with emergency response coordination and FDA inspections. Read more about the role and responsibilities of an FDA U.S. Agent.
Additional services
Consider us as a colleague and advisor if you are planning a new product or product design change, are not completely sure about compliance requirements, or have regulatory enforcement issues that you need to resolve. If you have any questions about these or other regulatory areas of expertise, please contact us.
Information request form
The form to request information about the services of Medical Devices and Pharma as a U.S. Agent/Correspondent follows.
