We assist our clients with regulations for the pharmaceutical requirements, such as IND (Investigational New Drug), NDA (New Drug Application) to name a few. OTC (Over-the-Counter) products are also required to be in compliance with the current monographs. Additionally, as the pharmaceutical industry is becoming more than ever innovative, your product may not fall into any of the above or fall into more than one of the above which will make things quite more complex. There are multiple factors in deciding which pathway to take, and we will layout what you need to know to make the most effective decisions.
Domestic and foreign drug establishments that manufacture, prepare, propagate, compound, or process drugs must register their drug establishment with the FDA. Foreign establishments that manufacture, repack, or re-label drug products for importation to the United States must register with the FDA and identify a U.S. Agent. The U.S. Agent is a person or entity that maintains an address in the United States who can serve as the facilities representative before the FDA. Every importer of drug products to the United States must provide to the FDA the drug facility registration number for the foreign drug manufacturer, repacker and/or relabeler. Failure to provide this information will result in a detention or refusal of the drug products.