drug administration Software Solutions

PharmaSuite - Manufacturing Execution System (MES)

FactoryTalk® technology. The software vendor is the American company Rockwell Automation. The system complies with the requirements of the Food and Drug Administration (FDA), the official drug regulatory agency of the United ...

By Systec & Services GmbH based in Karlsruhe, GERMANY. from MES Systems Software line

RegScan - Version MDR - Medical Device Reporting System

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 ...

By RegScan, Inc. based in Williamsport, PENNSYLVANIA (USA). from Quality Suite Checklists Software line

Design Control Software Systems

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 MasterControl, Inc based in Salt Lake City, UTAH (USA).

Freyr SPL-SPM - Structured Product Labeling/Monograph (SPL-SPM) Software

and content of label information as required by the United States Food and Drug Administration (US FDA) and Health Canada. The US FDA has mandated SPL requirements for over 50 types of documents, and HC has mandated SPM requirements for over 6 types of ...

By Freyr Solutions based in Princeton, NEW JERSEY (USA).

Phoenix - Version WinNonlin - Industry Standard for Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Software

the US FDA, Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), all use Phoenix WinNonlin to evaluate drug ...

By Certara based in Princeton, NEW JERSEY (USA). from Phoenix PK/PD Software Software line

Finapres - Software Application for Guided Automatic Testing

New GAT application enables standardization and quantification! In autonomic testing, standardized procedures are essential for reliable test results. Finapres Medical Systems developed a Guided Autonomic Testing (GAT) application as part of the Finapres® NOVA, which guides the operator and the patient through a series of autonomic test maneuvers. The GAT application consists of a graphical ...

By Finapres Medical Systems based in Enschede, NETHERLANDS.

Finapres - Guided Automatic Testing Software

New GAT application enables standardization and quantification! In autonomic testing, standardized procedures are essential for reliable test results. Finapres Medical Systems developed a Guided Autonomic Testing (GAT) application as part of the Finapres® NOVA, which guides the operator and the patient through a series of autonomic test ...

By Finapres Medical Systems based in Enschede, NETHERLANDS.

Codonics SLS - Administration Tool (AT)

Codonics award-winning Safe Label System (SLS) is the world’s leading solution for safe, compliant, and fast medication labeling — anywhere medications are prepared! An FDA Class 2 medication safety system, SLS uses barcode technology to improve safety, compliance and efficiency during medication preparation. SLS helps to eliminate vial and ampoule swaps, mislabeling, and syringe ...

By Codonics based in Middleburg Heights, OHIO (USA). from Formulary Management Software line

SKOUT - Endoscopy Solutions

SKOUT™ uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists, drawing their attention to potential areas of interest, with the goal of early lesion detection. Early detection is key in the effort to decrease the incidence of colorectal cancer, the second leading cause of cancer-related deaths in the United ...

By Iterative Scopes, Inc based in Cambridge, MASSACHUSETTS (USA).

Phoenix - Version 8.3 - Pharmacokinetic and Pharmacodynamic (PK/PD) Platform

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 Certara based in Princeton, NEW JERSEY (USA). from Phoenix PK/PD Software Software line

NantHealth Eviti - Version Connect - Empowering Confident Care Platform

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. ...

By NantHealth, Inc. based in Morrisville, NORTH CAROLINA (USA). from NantHealth Eviti - Eviti for Oncology Software line

Analyse-it - Method Validation Edition Software

Validate and verify your analytical and diagnostic methods to meet the demands of regulatory ...

By Analyse-it Software, Ltd. based in Leeds, UNITED KINGDOM.