Journal Articles related to Post-launch Outsourcing

Pages 31-32. According to the American Society for Quality, a quality management system (QMS) is a “formalized system that documents process, procedures, and responsibilities for achieving quality policies and objectives”. For companies in life science and pharmaceutical, maintaining a health QMS is crucial for ensuring compliance and adequate preparation for inspections.

Even though this is true in any business sector, it is particularly important for companies in the life sciences industry, where personnel must deal with many complex processes in a highly regulated environment to ensure both product and operations are compliant.

Companies must safeguard their mature portfolios while continuously innovating and developing new products. But in-house resources are stretched and often lack the broader knowledge needed to ensure best practices for ongoing maintenance activities. As a result, traditional models of outsourcing – the low-cost, “lift and shift” approach of the past – are giving way to a more nuanced, strategic approach. One that leverages external expertise globally and delivers more efficient methods for supporting the product lifecycle. Dr. Constanze Burkhardt, Vice President, Head of Program Management at Pharmalex, explores why outsourcing the mature portfolio has become an industry priority.