A Team of Experts to Improve Pharma Manufacturing Control Strategy

Pursuing growth into personalized medicine and safer, more effective drug therapy, an F200 biopharmaceutical company wanted to improve its cross-functional end-to-end control strategy and tactics for the manufacture of combination products. In an effort to accelerate the workstream development, a director in manufacturing reached out to Business Talent Group.

BTG delivered a cross-functional team of five consultants: a team lead (former Deloitte) with medical device and operations experience, along with four seasoned consultants with deep industry knowledge and drug/device experience. The team conducted benchmarking for client’s current medical device manufacturing processes and devised a detailed benchmark report. The team carried out a methodical and robust end-to-end gap analysis and risk-based “best practice” work plan for implementation and adaptation of near- and long-term actions supporting transformative improvements across key functional areas. This included a thorough review of current processes in manufacturing combination products and identification of solutions to ensure the elimination of product defects and minimize complaints. The consultants were able to identify and provide recommendations for process improvements, help ensure harmonization and alignment with suppliers, and develop a workstream dedicated to evaluating and delivering consistent execution across all functional groups.