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Drug Administration Software In North America
7 software items found
by:RegScan - by Enhesa based inWilliamsport, PENNSYLVANIA (USA)
The medical device reporting (MDR) requirements of 21 CFR 803 apply to manufacturers, importers, distributers, and device user facilities in the United States. Such facilities are required to report adverse device-related events to the Food and Drug Administration (FDA) or the device manufacturer, and occasionally to both. These requirements are supplemental to ...
by:MasterControl, Inc based inSalt Lake City, UTAH (USA)
Each manufactured medical device must be supported by appropriate documentation which demonstrates that its development followed the Food and Drug Administration's (FDA) design control guidelines. MasterControl offers design control software systems for the design history files (DHF) which are established for each device to house this documentation for the ...
by:Certara based inPrinceton, NEW JERSEY (USA)
It is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling with a proven 30-year history. Regulatory agencies, including the US FDA, Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products ...
Manufactured by:Stilla Technologies based inVillejuif, FRANCE
Electronic documentation offers many benefits, including increased efficiency and productivity when storing data and easier information sharing and data mining. The Food and Drug Administration (FDA) of the United States (USA) regulates the food and drug industry of the USA with the Code of Federal Regulations (CFR). The FDA is within the ...
by:AWS Truepower, LLC based inAlbany, NEW YORK (USA)
Medical technology advances quickly, and with it the need for compliance systems to support patient safety. To help you and your workforce stay up to date with the latest U.S. Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) training, HIPAAA training, ISO 14971 training and more, we created ComplianceWire®. ...
by:Certara based inPrinceton, NEW JERSEY (USA)
The one software ecosystem to streamline your PK/PD data management and analysis; With all the tools you need in a single, interoperable platform, effortlessly share pre-clinical and clinical knowledge across your organization through secure and consistent workflows using Phoenix-based tools and 3rd-party applications. Phoenix WinNonlin is the first choice for non-compartmental analysis (NCA), ...
by:NantHealth, Inc. based inMorrisville, NORTH CAROLINA (USA)
Payers, seeking a clearer view into treatment validity, turn to Eviti Connect. Focused on high-quality, high-value care, the platform offers insight payers need to make reimbursement decisions. For payers, Eviti Connect streamlines the authorization of cancer treatment, ensuring prescription of high-quality, high-value care and setting patients on the path to appropriate treatment sooner. ...