US Agent Services for Drug Companies for ANDA , NDA, IND and DMF filing – for Pharmaceutical and API manufacturers
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.
...Read MoreUS FDA Drug Establishment Registration Services & Renewal Process
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.
...Read MoreIND and NDA filing assistance
Pragmatic can act as your US Agent for the purpose of filling your INA and NDA applications.
...Read MoreGeneric Drug Application – ANDA Submission Process
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.
...Read MoreFDA 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. FDAbasics offers a complete solution for establishment registration, labeler code, NDC number assignment and drug listing services.
...Read MoreNO 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.
...Read MoreECTD Publishing Services
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.
...Read MoreFDA DMF Filing in eCTD format and US Agent for Drug Master File
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.
...Read MoreGDUFA 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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