IT&E International Launches CuroFDA(TM), First Fully Compliant Online Validation Lifecycle Tracking Software

International Group, http://www.iteinternational.com today announced release of CuroFDA(TM) Online Tracking & Inventory Management system for FDA regulated industries ( http://www.curofda.com ). CuroFDA is believed to be the world’s first solely focused application for the management of validation within the biotech and pharmaceutical industries that is fully FDA compliant and offers online validation lifecycle tracking.

According to Kelly Alberts, President and COO of IT&E International, “The need for development of a web-based process and productivity tool like CuroFDA first became apparent internally, as we searched for a method that would help our compliance and validation consultants deal with the myriad of approaches being used by many different IT&E clients with respect to their FDA compliance.

“With our internal IT resources, we developed CuroFDA, which easily interfaces with several different systems used by our client base, and is a state-of-the-art FDA regulatory compliance solution and productivity tool for IT&E,” Mr. Alberts continued.

“Designed and developed by life science professionals, CuroFDA enables the user to set security controls, features a built-in memo/reminder system, provides complete audit trail and change control, and is web (n-tier) based. CURO dramatically reduces FDA exposure, and post-implementation automatic operation frees up internal IT resources for other duties,” Mr. Alberts said.

“Industries regulated by the FDA were facing a void for a validated, fully FDA compliant inventory tracking system with built-in e-signatures capability. IT&E recognized this need and opportunity to create a competitive advantage, and developed CuroFDA as the first web-based tool specifically targeted to the biotech, pharmaceutical and medical device industries that will greatly simplify FDA compliance tracking. We feel CuroFDA will give IT&E a cost, quality and ongoing competitive advantage and position IT&E as both the quality leader and the thought leader that has turned a vision into reality in a short period of time,” added Mr. Peter Sollenne, CEO of IT&E International.

About IT&E International Group

IT&E focuses on providing leading pharmaceutical, biotechnology and medical device companies with project-based consulting services in the areas of FDA regulatory compliance, data management, biometrics and clinical validation throughout the clinical trials lifecycle. The company, with its talented team of industry veterans with many years of biopharma experience, utilizes the latest tools and procedures to help its clients move quickly and effectively through the FDA approval process. The company’s pharmaceutical, biotech, medical device, healthcare and other life science client list includes such well-known companies as Abbott Laboratories, Amgen, Aventis Pasteur, Baxter Pharmaceutical, Bayer, Boston Scientific, Bristol-Myers Squibb, Chiron, Eli Lilly, Genentech, GlaxoSmithKline, Novartis, Pfizer, Purdue Pharmaceuticals, Schering-Plough, VaxGen, and Wyeth Global.