NEEDHAM, MA–(Marketwired – Sep 4, 2015) – The Windshire Group, LLC, a global consulting group providing comprehensive consulting services to biopharmaceutical, pharmaceutical, medical device, cell therapy companies and industry investors, today announced the launch of Stabilityshire(SM), a drug stability and shelf-life data analysis, assessment, reporting and management service. The service allows organizations to supplement internal capabilities, or to completely outsource their stability data management and analysis requirements, while accessing world-class expertise.
The StabilityshireSM service evaluates stability data to determine the appropriate shelf-life for new drugs, and to monitor ongoing stability performance. The service is fully compliant and based on a cGMP quality system, and uses fully validated trend analysis software that is compliant with cGMP, ISO and ICH Q1E requirements. It produces stability reports, including trend analysis, and provides authorship of the stability sections of regulatory submissions — such as INDs, IMPDs and NDAs. The service can manage entire stability programs, including outsourcing and stability testing at CROs and CMOs. For current or ongoing stability programs, StabilityshireSM can also assess these for cGMP and ICH compliance.
“We have been very pleased with our clients’ response to the StabilityshireSM service offering,” said James Blackwell, Ph.D., President and Principal Consultant, The Windshire Group. “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 Continued Process Verification offering for ongoing process and manufacturing data analysis and management.”
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