The Windshire Group, LLC (windshire.com) is a global consulting firm that provides comprehensive CMC (Chemistry, Manufacturing, and Controls) and management consulting services and solutions to pharmaceutical and biopharmaceutical (oral and parenterals), vaccine, medical device, and cell therapy companies, and their investors.Our expert CMC and management consultants are industry veterans with broad, global experience within product companies and as consultants. Our team has worked with virtual companies to global conglomerates during all phases of the product life-cycle and on all aspects of CMC. We excel at surpassing client expectations whether it be a solo, short term consultation, or as an integrated, high performance team meeting the steepest challenges within the industry. Visit www.windshire.comStabilityshire- intermediate, drug substance, drug product stability and shelve life data analysis, expert consulting, reporting, and CRO and data management using validated software and quality management system for compliant reportsProcessPad- software for continued process verification: quality, process, manufacturing data analysis, trending, reporting, ARCC- audit ready compliant cloud software and hosting for QMS, eCTD, EDMS, ProcessPadInformashire- information research service and digital librarian, including access to industry databases

CMC pharmaceutical and biotechnology consulting Drug product stability data analysis reporting management Due diligence Value creation for unwanted or neglected products Consultant resource to other 3rd Party Consent Decree and Remediation Consultancies CMC biopharmaceutical and pharmaceutical consulting Due diligence and auditing Value creation for unwanted products Consultant resource to third parties Earned Value Analysis (EVA) for portfolio and program management Quality Regulatory Compliance Pharmaceuticals Biopharmaceuticals Cell Therapy Personalized Medicines Process Validation Data Integrity Process Development Manufacturing Supply Chain Automation Operational Excellence Data Integration