Operational Excellence, including Training, Certification and Deployment

Catalyzing change in today’s business and compliance environment is not easy. Pharmatech is an industry-leading consultancy as evidenced by the fact that we were the first services organization in the US to develop a Lean Six Sigma (LSS) approach geared specifically to the regulated life sciences. With decades in LSS program design and deployment we are ready to assist you in implementing a tailored Operational Excellence program that will allow you to realize the business benefits from greater efficiency or greater productivity. Pharmatech has designed and successfully implemented LSS programs in the product development and commercial components of the product development lifecycle. We have adopted the tools and philosophies developed for other industries such as the Toyota Product Development Systems and Product Systems DMAIC, DFSS and DFS to create a focused and effective program and methodology for the regulated life sciences industry.


Pharmatech Associates’ team of Lean Six Sigma Master Black Belts and Black Belts have a long history of successfully implementing operational excellence programs within the life sciences industry. Pharmatech has training and certification classes that are powerful, regardless of industry. Within the life sciences industry Pharmatech has developed a training program geared specifically for the medical device, pharmaceutical and biotechnology industries. The result is our students leave our classes with a clear understanding of how these techniques can immediately be applied in their workplace.

If deployment is your focus, our Lean Six Sigma experts have cultivated a reputation throughout the industry for their success in leading, and successfully completing, programs and projects.


Effective Root Cause Analysis (RCA) has come into focus as one of the key attributes within an organization’s Non-Conformance, CAPA and Operation Excellence programs. Pharmatech has developed a robust framework for applying RCA that is both simple to learn and effective when applied. Our experts can provide RCA support ranging from specific facilitation and technical leadership for troubleshooting to creating and providing competency based training programs for your organization. Pharmatech’s unique RCA systems and toolkits have been lauded by US and European regulatory authorities consistently as part of regulatory surveillance audits.


Design for Six Sigma (DFSS) seeks to avoid manufacturing and service process problems by using advanced Voice of the Customer techniques and proper systems engineering techniques to avoid product and process problems at the design stage where they can quickly and cost effectively be remediated. As the current regulatory philosophy moves towards scientific understanding at the design stage, DFSS offers a structured and effective means of maximizing the potential for commercial success as your program moves through development.

Pharmatech has training and certification classes that are powerful, regardless of industry. Within the life sciences industry Pharmatech has developed training programs geared specifically for medical device, pharmaceutical and biotechnology industries.


Design for Manufacturability (DFM) is the science of designing a process or products for ease of manufacturing at the design stage. Leveraging principles of mistake proofing and integrating the appropriate variation reduction and lean manufacturing tools in a structured framework, DFM allows you to minimize the number of parts and assembly steps which contribute to cost and cost of poor quality.

Pharmatech’s experienced approach to DFM integrates its understanding of medical device, pharmaceutical and biotechnology processing and compliance requirements with a proven framework in order to help your organization extract and realize the hidden costs within your operation.


Driving efficiency into the product development lifecycle is an essential element in catalyzing business performance. Pharmatech has adapted the proven principles of organizational efficiency defined in the Toyota Product Development Systems and the Toyota Production System and have adapted them to meet the unique requirements of the regulated life sciences industry. If Time to Market or capacity are an issue for your organization our training and deployment services are geared to meet the specific needs of your R&D and manufacturing environment.