Drug Establishment Registration Application:
Once you have determined that your business needs to register with the FDA, you can begin submitting your registration application. This process involves submitting a form and relevant details about your business such as its name, address and contacts. You also need to provide information about the types of products being manufactured, whether drugs or medical devices, to complete the initial registration application.
Submit Additional Required Documentation and Fees:
After the initial registration application is submitted, you may need to provide additional required documents and pay any applicable fees. Depending on the type of product your business produces, you may be asked to submit specific documents such as labels, copies of product packaging, quality assurance plans and other forms of required documentation. In addition, you may need to pay annual fee for drug establishment registration.