ST&T Research can submit New Drug Applications (NDA) or Abbreviated New Drug Applications – Generics (ANDA) to the FDA.
The NDA is the procedure through which drug sponsors formally apply for FDA approval for a new pharmaceutical product for sale and marketing in the U.S. With the NDA, drug sponsors must provide enough information to FDA to prove the drug is safe and effective in its proposed use(s), and the benefits of the drug outweigh the risks. Drug technical data must be submitted with the NDA.
Abbreviated New Drug Applications (ANDA) must scientifically demonstrate that the product is bioequivalent to the innovator drug.
ST&T can assist you in gathering and preparing all the information required to submit a NDA or ANDA as well as submitting the application for the new drug listing and drug establishment registration. We can also assist you in the design or review of the labeling to make it comply with the FDA requirements. If necessary, we can review the methods used in drug manufacturing as well as the quality control in order to comply with the cGMP’s for drug manufacturing facilities.
With ST&T Research Intl acting as your FDA official correspondent, we will be responsible for the annual registration of the establishment and the device listing. ST&T will be also available to assist you with the labeling and Medical Devices Master Files.
An over-the-counter (OTC) drug must be recognized as safe and effective, it must meet the FDA regulatory requirements as well as the conditions contained in any applicable monograph. ST&T Research Intl can assist you in properly register your product(s) avoiding fail to conform the FDA requirements.
The US FDA & CUSTOMS (and most other importing countries) require that any domestic or foreign manufacturer and/or distributor who ships into/out of the country must have a local agent who can respond to FDA NDC filing/reporting, and Customs, legal and regulatory matters or questions which may arise concerning their products. ST&T has specialists who provide clients with these Regulatory Agent Services.
Acting as your U.S. Agent, your Company will be provided legal & science support for its efforts to market products in the USA.
Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. ST&T can transfer your Drug Establishment Registration and Drug listing Information to the new electronic system.