Carmody Quality Solutions

Life science start-up companies need to move quickly yet bringing a new pharmaceutical product to market is a unique process based on a number of regulatory requirements. Beginning at the discovery or early development stages, these companies must understand the regulatory landscape and know how to navigate the drug development process. This helps them to make better, early decisions that lead to future success. With corner-office expertise and “street-level” quality and operations experience, Carmody Quality Solutions, LLC (CQS) is a boutique business advisory to life science startups and investment firms. Business owners, entrepreneurs, and investors seek our help to navigate the challenging drug development process – from research to patient. CQS focuses on improving R&D efficiency and performance through strategy, quality culture, management, and operations consulting. We deliver and implement customized strategies that translate your innovation to success and accelerate your product’s path to market. Our consultants have extensive knowledge and experience in quality and GxP operations (including clinical, non-clinical, Chemistry, Manufacturing and Controls (CMC), and IT) and acquisition or investment due diligence. We provide support from professional advice and expertise to interim management, hands-on implementation, and training. Offering Expertise in: • Due Diligence ▪ Data Integrity • Operational Strategic Planning and Implementation • Training and Developing Training Programs • Auditing • Building and Leading Operations and Quality Teams • Equipment Calibration/Maintenance Programs • Building and Implementing Corporate Quality Cultures • Event Investigations/CAPAs • Method Validation/Method Transfer • Validation • Vendor Selection and Management • GMP/GLP/GCP Compliance • Building Quality, Clinical, CMC, Supply Chain, IT, and Laboratory Systems We welcome the opportunity to discuss how we can assist you to meet your corporate goals.