Innovation Management, Just-in-time and Kaizen Case Study in a Multi-National Pharmaceutical Company Working on ANDA Para III and IV Drug Products

​Innovation Management, Just-in-time and Kaizen Case Study

Problem:  An multi-national pharmaceutical company had an ambitious goal of new product introductions into several developed markets including US (20 products ANDA para III and IV), Brazil (36 products) , Canada (5 products) and Australia (3 products) to be accomplished over a period of 2 years. All the products were new to the company and they wanted to be 2nd or 3rd player in the market.

All the products had to be developed first, followed by regulatory submissions for getting  marketing approvals in US, Canada, Brazil and Australia. The company also wanted to know the LCM for each of the products in order to create appropriate yearly budgets.

Solution:  The Innovation portfolio was strategically designed. Potential value stream maps were designed for each new product and all concerned standard operating processes were put in place. Product development, regulatory, IP, manufacturing, testing, pricing and logistic strategies were developed along with their respective plan for implementation. LCM protocols were submitted to the company’s management board.

Design Thinking, QbD and DOE were employed to succeed with the innovation portfolio. Kaizen and Just-in-time methodologies were applied to bring about a culture of innovation within the organization.

Result Dashboard:  

• Product approvals for all products was received in time as per schedule.
• Profit margins further improved as Lean methodology was employed to operations which saved overheads by 18- 20%.

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