Services to Ease FDA Regulatory Compliance

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NO CHANGES CERTIFICATION OF PRODUCT LISTING November 10, 2017

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.

NADA and ANADA Filling Assistance September 2, 2017

Pragmatic can act as your US Agent for the purpose of filing your NADA and ANADA applications.

IND and NDA filing assistance September 2, 2017

Pragmatic can act as your US Agent for the purpose of filling your INA and NDA applications.

FDA Food Facility Registration November 7, 2016

Pragmatic 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.

FSVP Compliance Services July 11, 2017

The Foreign Supplier Verification Program sets out the regulation for food imported to the United States. Pragmatic offers services to act as representatives of foreign manufacturers for the FSVP compliance program.

FDA Food & Dietary Supplement Labeling Requirements April 3, 2017

Pragmatic 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.

MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND DEVICE LISTING November 7, 2016

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. Pragmatic Compliance LLC offers FDA medical device registration and listing services at competitive fees.

PRE MARKET NOTIFICATION 510 (K) November 7, 2016

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.

PMA (PREMARKET APPROVAL) November 7, 2016

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.

HDE (Humanitarian Device Exemption) November 7, 2016

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.

INVESTIGATIONAL DEVICE EXEMPTION (IDE) November 7, 2016

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 SUBMISSION November 7, 2016

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.

US AGENT SERVICES FOR FOREIGN FOOD COMAPNIES November 7, 2016

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.

FDA Food Labelling Requirements April 3, 2017

Labelling is one of the important regulatory  requirement for  food products marketed in the United States. Incase, food product label fail to meet FDA requirements, FDA may take strict regulatory action. We offer complete assistance for  to meet FDA food labelling  requirements. Additionally, we provide  food product label designing services at competitive fees. Our fees … Continue reading FDA Food Labelling Requirements

ESTABLISHMENT REGISTRATION & PROCESS FILING FOR ACIDIFIED AND LOW-ACID CANNED FOODS (LACF) SID Number November 7, 2016

Pragmatic Compliance provides registration & process filing for Acidified and Low-Acid Canned Foods at competitive fees of just $600.

PRIOR IMPORT NOTIFICATION November 7, 2016

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 $50.

SERVICES FOR COSMETIC COMPANIES November 7, 2016

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.

COSMETIC LABELING REQUIREMENTS FDA November 7, 2016

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.

US FDA Agent Services for Foreign Companies November 7, 2016

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. Pragmatic Compliance LLC can act as your agent, and provide services to support you with the FDA regulations.

US Agent Services for Drug Companies November 7, 2016

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. Pragmatic Compliance LLC provides a comprehensive service to support you.

Generic Drug Application – ANDA Compilation & Review November 7, 2016

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.

ECTD Publishing Services November 7, 2016

eCTD publishing – or electronic common technical document filing – is a mandatory requirement for all regulatory submissions from May 2018. Here at Pragmatic, we offer a complete solution for eCTD publishing services.

DRUG MASTER FILE SUBMISSION November 7, 2016

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.

GDUFA SELF IDENTIFICATION November 7, 2016

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.

GDUFA SELF IDENTIFICATION November 7, 2016

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.

FDA Drug Listing & NDC Number Registration Services November 7, 2016

It is a mandatory requirement for drug companies to register their manufacturing facility and list the drugs under commercial distribution. Pragmatic offers a complete solution for establishment registration, labeler code, NDC number assignment and drug listing services.

FDA Registration (Establishment Registration) and Renewal October 13, 2016

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.

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