Windshire Launches Stabilityshire, Enables Outsourcing for Stability Data Analysis, Reporting and Management
NEEDHAM, MA: Providerof Global consulting services and solutions, The Windshire Group announces the launch of its new service Stabilityshire. Stabilityshire is a drug stability and shelf-life data analysis, assessment, reporting and management service.
The Windshire Group provides comprehensive services to long clientele list which include biopharmaceutical, pharmaceutical, medical device, and cell therapy companies, and industry investors. And this new solution will aid them to completely outsource their stability data management and analysis requirements or supplement internal capabilities, along with getting an access to word-class expertise.
James Blackwell, Ph.D., President and Principal Consultant expresses his pleasure over the overwhelming response of the clients on Stabilityshire service, and quotes "It is an excellent complement to our comprehensive consulting services and increases our ability to meet our clients' drug development and compliance needs. It also fits our long term strategy to offer industry leading comprehensive data analysis and management services, such as our ProcessPad offering for ongoing process and manufacturing data analysis and verification."
The services provided by Stabilityshire include evaluation of stability data while determining the appropriate shelf-life of newly developed drugs and also monitor the ongoing stability performance of the same. For compliancy standards, the service sports a grade for cGMP quality system and uses a fully validated trend analysis software which is again compliant which cGMP, ISO and ICH Q1E requirements. It can generate stability reports which also trend analysis. It can provide authorship of the stability sections of regulatory submissions such as INDs, IMPDs amd NDAs. The service also holds the capabilities to manage entire stability programs, including outsourcing and stability testing at CROs and CMOs. For current or ongoing stability programs, Stabilityshire can also assess these for cGMP and ICH compliance.