About Umbra Global

UMBRA is an innovative company providing a broad range of products and services to the Life and Health Science communities. The company has been developing its products and services for over 10 years with an absolute focus on Heath IT, Pharmaceuticals, Biologics and Medical Devices.
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UMBRA Global’s pvSafety has been selected by VI.REL Pharma as their pharmacovigilance platform of choice. Prof. Paolo Biffignandi, Executive Director says, “VI.REL is a well-known provider of pharmacovigilance services in Europe for many years and we selected pvSafety for its rich set of features, user-friendly interface and affordable pricing structure which allows us to comply with legal obligations on behalf of our clients."

CloudPcV - Connect with Your Patients

U|Safe Web Based Patient Care Platform from UMBRA Global Beyond meeting efficacy and safety requirements, new medical products are expected to provide new levels of value: • Addressing unmet medical needs • Delivering outcomes that improve quality of life • Communicating with patients in more meaningful ways

UMBRA Case Study

Microsoft Corporation publishes a case study highlighting UMBRA Global's use of their Azure Cloud platform

FDA releases Three Nanotechnology Guidances

June, 2014, the FDA issues three final guidances related to nanotechnology applications in regulated products, including cosmetics and food Substances.

FDA releases Mobile App Guidance

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.

FDA Monitoring Guidance

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 Case Study

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.

UMBRA DSI Announce Partnership

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.

ICH E2C R2 New Draft Guidance FDA

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 ...

pvSafety Released

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 ...

FDA guidance agenda for 2013

The FDA has published their planned guidance agenda for New & Revised Draft Guidances for CDER.

Umthunzi and AIM-CIO Merge to Form UMBRA Global

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.

vrSafety Certified for Windows Server 2012

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.

Affordable Cloud Safety Solutions


The release of vrSafety provides Life Sciences organizations with the industry’s first “built for the Cloud” safety and pharmacovigilance application. The implications for the industry are dramatic. The benefits of the global Microsoft Azure® cloud-based services infrastructure allows globally dispersed companies to use a single application to manage all their safety cases in a single standards-based solution.

Affordable Cloud-based Drug Safety for the Biotech community


UMBRA has announced the availability of pv-Biotech. This unique solution provides the Biotechnology industry with a powerful yet affordable tool for managing their safety with out the burden of purchasing hardware or the cost of the traditional software solutions on the market today. How does it work? Clients join pv-Biotech by paying a simple membership fee.

Solutions for Life & Health Sciences

UMBRA Consulting

UMBRA provides a wide range of consulting services that encompass technology, compliance, and validation. All engagements are designed to provide our clients with a clear “current state” report and then the recommended measures to achieve the desired “future state.” This “GAP analysis” is an integral part of our consulting service.

Safety Solutions In the Cloud

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    Comprehensive & Intuitive

    vrSafety provides Pharmaceutical organizations with the industry’s first ”Ready-to-Run” safety and pharmacovigilance application. The implications for the industry are dramatic. vrSafety gives complete control of the safety systems without requiring customers to set up complex, costly, on-premises infrastructure.

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    Finally Affordable

    This unique and affordable solution provides the Biotechnology industry with a powerful yet affordable tool for managing their safety with out the burden of purchasing hardware or the cost of the traditional software solutions on the market today.

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    Device Safety Affordable & Easy

    With vrSafety, medical device manufacturers have an affordable and easy to use solution that addresses the safety reporting requirement of the industry. With vrSafety, there is no infrastructure to purchase, nor is there a long and complex implementation and validation period.

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    Safe Clinical Trials, Affordably

    UMBRA has announced the availability of pv-CRO. This unique solution provides CRO's with a powerful yet affordable tool for managing their safety without the burden of purchasing hardware or the cost of the traditional software solutions on the market today. How does it work? Clients join pv-CRO by paying a simple membership fee.