Services to Ease FDA Regulatory Compliance

Services: DRUGS

NO CHANGES CERTIFICATION OF PRODUCT LISTING

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.

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IND and NDA filing assistance

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

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US Agent Services for Drug Companies

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.

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Generic Drug Application – ANDA Compilation & Review

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.

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ECTD Publishing Services

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.

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DRUG MASTER FILE SUBMISSION

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.

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GDUFA SELF IDENTIFICATION

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.

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FDA Drug Listing & NDC Number Registration Services

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.

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FDA Registration (Establishment Registration) and Renewal

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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