ArisGlobal’s industry-leading regulatory software chosen by top pharmaceutical company for IDMP preparation and global readiness
MIAMI, Feb 15 – ArisGlobal, the leading provider of life sciences software that automates core drug development with its end-to-end technology platform LifeSphere® today announced a top 5 pharmaceutical research and development company has chosen LifeSphere IDMP to identify issues, overcome challenges, and achieve readiness and compliance regarding the Identification of Medicinal Products (IDMP) standards. The selection of LifeSphere IDMP marks an added solution to the pharma company’s LifeSphere technology stack, which also includes LifeSphere MultiVigilance, the industry’s leading safety case processing software.Notably, the company is a US based biopharmaceutical leader with significant global operations, highlighting the relevance of IDMP compliance for pharma, biotech, and medical device companies even if their operations are based outside of the EU-specific regulation.
“Today, teams are working collaboratively at a global scale, proving that country-specific compliance standards are now applicable for all teams, regardless of the location of their headquarters,” shares Pat Jenakanandhini, Chief Product Officer at ArisGlobal. “IDMP should be considered a framework for investing in processes and technology to not only achieve compliance in the EU, but to maintain it, while also addressing the end-to-end processes throughout the regulatory lifecycle from a global perspective.”
As a secure validated cloud solution, LifeSphere IDMP adapts over time to support the regulatory journey through continued xEVMPD compliance, multiple phases of IDMP compliance, UDI, and beyond. LifeSphere IDMP is a simple-to-use, ISO IDMP cloud application that specifically addresses the challenges of implementing Identification of Medicinal Products (IDMP) standards. With LifeSphere IDMP, life sciences companies can achieve compliance with xEVMPD, IDMP, UDI, SPL, and other standards, and collect data in an ISO IDMP-compliant fashion.
The news comes following regulatory analyst recognition for LifeSphere IDMP by Gens & Associates as the most-ready technology for pharmaceutical, biotech, and medical device companies, among others. This week, ArisGlobal presented at DIA RSIDM on global organization readiness for IDMP.