June, 2014, the FDA issues three final guidances related to nanotechnology applications in regulated products, including cosmetics and food Substances.
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of mobile apps the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps.
The FDA announced their new Guidance Oversight of Clinical Investigations — A Risk-Based approach to Monitoring. This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting.
pv-BIOTECH is based on UMBRA’s vrSafety™ platform, which leverages the strengths of Microsoft’s Azure™ cloud-based infrastructure, in order to provide companies with a validated, redundant and secure environment for collecting, storing and querying their clinical and safety data, at a cost substantially less than those offered by competitors. The pv-BIOTECH™ solution provides small and mid-size biotech companies access to powerful, cloud-based tools for managing their safety data capture and reporting without the burden of purchasing hardware as well as incurring the significant upfront cost of acquiring and imple ...
Opus IRB turned to Umbra Global, a member of the Microsoft Partner Network, and deployed vrSafety, its pharmacovigilance solution built for the Windows Azure cloud.
Alpharetta, GA, June, 21st 2013. Down South Innovations (DSI) has entered into a partnering agreement with UMBRA Global, LLC that combines the most comprehensive source of Biotech information in the Southeast with UMBRA’s advanced technology offerings and compliance expertise to provide innovative solutions for life and health sciences.
April 2013, the FDA issued a Guidance for Industry "Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) (Periodic Benefit-Risk Evaluation Report) Format" This guidance describes the conditions under which applicants can use an alternative reporting format, the International Conference on Harmonization (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the U.S. periodic adverse drug experience report (PADER), U.S. periodic adverse experience report (PAER), or ICH E2C Periodic Safety Update Report (PSUR), to satisfy the periodic safety reporting requirements at 21 CFR 314.80(c)(2) and 600.80(c)(2). (More on exter ...
Imagine your own Drug Safety Solution with no infrastructure, no hassles, and installed and validated in less than a week. Biotechnology companies finding automation and the new electronic submissions requirements from the regulatory authorities both costly and cumbersome now have a simple, affordable solution for keeping track of their Serious Adverse Events (SAE's) and Adverse Events (AE's). pv-Biotech, from UMBRA, is a dynamic solution built on the powerful vrSafety pharmacovigilance platform but with greatly simplified installation, validation, and maintenance. How do we deliver such powerful features, implementation, and support services? With the advent of ...
The FDA has published their planned guidance agenda for New & Revised Draft Guidances for CDER.
The merger between Umthunzi and AIM-CIO has resulted in a new company, UMBRA Global. The combined capabilities of Umthunzi, a software development company dedicated to designing high quality software solutions for the Life Science industry, and AIM-CIO, a consulting group focused on providing services and consulting to Life and Health Sciences companies, means the new company UMBRA is well positioned to provide industry leading products and services to its Clients.
Alpharetta, GA, December 8, 2012 – UMBRA today announced vrSAFETY has been certified for Microsoft Windows Sever 2012 and Microsoft private cloud environments. UMBRA has invested heavily in the Microsoft technology stack to ensure customers a seamless path to the latest release of Windows Server. In addition, UMBRA continues support for clients with on-premise installations of Windows 2008 R2.