Any foreign company involved in the processing, manufacturing, packing, testing or the performance of any operation on the drug products or drug substance within the United States must appoint a US Agent. FDAbasics provides a comprehensive service to support you.
Pragmatic can act as your US Agent for the purpose of filing your NADA and ANADA applications.
Pragmatic offers a complete solution to support organizations through the Drug Establishment registration and renewal processes. There are no FDA charges for registration, so we can keep our fees low, at just $299. It takes four working days to complete establishment registration. We also offer discounts for multiple facility registration.
The appointment of US Agents is a mandatory requirement for foreign companies who wish to market their food products in USA. Here at Pragmatic, we have established experience of providing US Agent services.
FDAbasics offers FDA Food Facility Registration services and US Agent services to foreign companies. We provide a complete service for food facility registration, drawing on over twenty years of experience.
FDAbasics offers a complete solution in dietary supplement labeling consulting. We also provide, product label design services at competitive fees. Our services help you meet FDA labeling requirements.
Companies who are involved in manufacturing, testing, packing, labeling, sterilization or import of medical devices are required to register their facility, pay FDA registration fees, and list their devices with the FDA. FDAbasics offers FDA medical device registration and listing services at competitive fees.
Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed. We provide complete assistance for Pre-Market Notification 510(k), at highly competitive fees. Please contact us for more information.
Most Class III devices require Pre-Market Approval, or PMA. The PMA is the most stringent type of pre-market submission. We provide complete assistance for Pre-Market Approval at highly competitive fees.
Humanitarian Device Exemption – or HDE – provides a regulatory path for Class III devices that are intended to benefit patients with rare diseases or conditions. If you are looking for any further assistance for HDE, Pragmatic can help.
An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study to collect safety and effectiveness data, which can be required for Pre-Market Approval applications or a Pre-Market Notification. We provide support for IDE.
De Novo provides a way for a new device, without a valid predicate, to be classified into Class I or II if it meets certain criteria. Pragmatic can help you with the preparation of your De Novo submission.
The Foreign Supplier Verification Program sets out the regulation for food imported to the United States. FDAbasics offers services to act as representatives of foreign manufacturers for the FSVP compliance program.
Labeling is one of the important regulatory requirement for food products marketed in the United States. In case, food product label fail to meet FDA requirements, FDA may take strict regulatory action. We offer complete assistance for to meet FDA food labeling requirements. Additionally, we provide food product label designing services at competitive fees. Our … Continue reading FDA Food Labeling Requirements
FDAbasics provides registration & process filing for Acidified and Low-Acid Canned Foods at competitive fees of just $600.
The FDA Food Safety Modernization Act requires that prior notification is given to the FDA of food – including animal feed – that is imported or offered for import into the United States. Pragmatic can provide Prior Import Notification at competitive fees of just $20.
Under the law, cosmetic products and ingredients do not need FDA pre-market approval, except for color additives. However, the FDA can pursue enforcement action. Choose Pragmatic to stay on the right side of the regulations.
Pragmatic Compliance offers a complete solution to ensure that companies can comply with all the applicable cosmetic products regulation. This includes label design, and a review of the format and content of your cosmetic product.
The appointment of a US Agent is a mandatory requirement for foreign companies who wish to sell drugs or pharmaceuticals, medical devices, food and dietary supplements, in United States. We can act as your agent, and provide services to support you with the FDA regulations.
Pragmatic can act as your US Agent for the purpose of filling your INA and NDA applications.
Abbreviated New Drug Application – or ANDA – submission is the process for generic drug approval by the FDA. Read more to find out how Compliance can help you save time and money with our complete support service.
It is a mandatory requirement for drug companies to register their manufacturing facility and list the drugs under commercial distribution. FDAbasics offers a complete solution for establishment registration, labeler code, NDC number assignment and drug listing services.
Get no change certification for your product listing quickly at flat fees $ 299, It will take just two working days to complete no change certification for product listing. If you fail to submit no change certification , your products will be considered as misbranded and adulterated.
eCTD publishing – or electronic common technical document filing – is a mandatory requirement for all regulatory submissions from May 2018. Here at FDAbasics, we offer a complete solution for eCTD publishing services.
The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that human generic drug facilities, and certain sites and organizations identified in a generic drug submission, provide identification information annually to FDA.
A Drug Master File – or DMF – is a submission to the FDA that provides ‘confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. We can provide complete support to guide you through the process.
Pragmatic offers a completed solution to GDUFA self-identification, including assistance with FEI and DUNS numbers, and technical support on SPL or XML conversion. We will guide you through all parts of the process, and stay with you until you have completed self identification.