United Pharma Technologies Inc. is one of the leading pharmaceutical software consultants in the US market. It has been serving the major Pharma Companies like Johnson and Johnson, lncyte Pharma, Opthotech, etc for the past two years. Now the company has forayed into a pharmcovigilance software product called Pharmus to serve the markets of US & Europe.
Pharmus, a pharmacovigilance and drug safety management solution software provides a comprehensive and holistic solution for clinical and post marketing safety. It includes case management, report preparation, electronics submissions and benefit & risk management as per the various Pharmaceutical regulatory authorities like ICH, FDA. EMA etc and other national drug regulatory authorities in the US where as in global scale it has to meet the regulations of different national and international drug regulatory commissions.
In pharmacovigilance, the new drug trails are innumerous and continuously evolving and the number of previous drug trials is almost infinite. So it is essential to have a record of drug react ions, benefits and risk associated with them, which helps the pharmaceutical companies to avoid repetitive and superfluous trails.
Human pharmacovigilance solution (including ICH E2B).
Process spontaneous and clinical trial adverse event cases.
Process product defects and technical enquiries.
Follow a quality process with case approval.
Apply standardized assessments.
MedDRA / VeDDRA coding included.
Generate compliant validated electronic reports to US and European agencies.
Generate all common paper report formats including CIOMS, MedWatch, FDA, CVMP.
Generate all common aggregate reports, including PSUR, DSUR and summary tabulations.
Generate reports in batch mode.
Built-in Gateway for electronic submission.
The Pharmus software has been built with a lean and user friendly interface and it is built with a simple two package system than a chaotic multiple packages unlike other products.