Author: Nigel J Smart PhD

Case Study: Divestiture of a Prescription Generic Pharmaceutical Pursuant to an Federal Trade Commission Consent Order

An acquisition of a generic pharmaceutical company by a larger generic company (Respondent) resulted in a Federal Trade Commission Consent Order that required the divestiture of a prescription pharmaceutical product to a third party acquirer. The responsibility of Smart Pharmaceutical Consulting (SCG) was to act as the Interim Monitor for the divestiture to review and evaluate the Respondent: (1) the transfer of product and technology, the transfer of the business and marketing information, and (3) the implementation of the technology by the acquiring company and (4) the subsequent post transfer verification that the Respondent company did not have access to the Confidential Business...

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Case Study: Lean Laboratory Process for Medical Device Company

A medical device manufacturer had a failing QC testing group. Sister facilities in Europe had a higher rate of productivity and much higher rate of efficiency in terms of fewer laboratory investigations and samples analyzed. The project was to analyze the situation and produce a new lean laboratory solution to establish at least parity with the European laboratory. The Process: Both laboratories were assessed using a proprietary Smart Pharmaceutical Consulting tool and the results were process mapped to elucidate the differences between the laboratories. Following this process the analytical laboratories were reviewed for similarities and a best practice was developed for the process going forward. With the best practice in place a gap analysis was developed and a forward implementation plan was crafted. Part of the solution was a total Lean Laboratory design of the analytical laboratory as well as an upgrade of the operating practices. Outcome: The result of the project was a vastly improved operating situation with reduced laboratory investigations and an improved level of productivity and operating efficiency incorporating Lean Laboratory design and operating...

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