601 N Mur-Len Road, Suite 9,
Olathe, Kansas, 66062, USA
We have more than 10 years of experience working the FDA throughout the pharmaceutical industries submitting PIND, INDs, ANDAs and NDAs. We carefully consider all strategies and alternatives during each step of regulatory process, helping you register products without costly delays.
The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER).
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug substance or drug product imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.
Drug establishments are required to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed for sale in the U.S. at their facilities.
Owners or operators of drug manufacturing establishments are required to register their establishments with FDA.
Facilities must apply for Facility Establishment Identifier (FEI), a unique identifier designated by FDA to assign, monitor, and track inspections of regulated firms.
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.
601 N Mur-Len Road, Suite 9,
Olathe, Kansas, 66062, USA