Pharmaceutical and Biotechnology
We help our clients deliver high performance manufacturing facilities and reliable operations to meet the needs of a global patient population. We have a strategy we use to the benefit of our clients:We focus on product and process understanding as the basis for the operating strategy, process control strategy, and overall quality system. We integrate the people, the process, and the equipment, systems and facilities into a high performance manufacturing operation. What does the product require from the process, the people, and the equipment in order to achieve quality specifications? If we answer this question, compliance becomes easy. In other words, we remove the excess cost of compliance and replace it with a reliable, quality operation that adds to your bottom line.
This strategy results in our clients’ ability to drive down the cost of goods and increase operational efficiency, while still providing the high-quality and compliant lifesaving products their patients need.
We not only work for our clients—we work for our industry as a whole and the patients it serves. Our industry is awash with new products and new manufacturing technologies. As the leader in commissioning and qualification services,, we are continually showing our commitment to the pharmaceutical and biotechnology industries with innovative, time and money-saving approaches. We are actively involved in industry professional societies at the local and national level, chairing committees, writing guidance documents, and taking leadership roles in evolving and streamlining processes and regulations.
Representative clients
- Eli Lilly and Company
- Merck
- Johnson & Johnson
- Novartis
- Amgen
- Roche / Genentech
- Biogen
- Cook Pharmica
- Numerous others including small startups
Services
- Commissioning, Qualification, and Validation
- Process and Concept Design
- Capital Project Delivery
- Operations and Continuous Improvement
- Product Realization Consulting
- Quality and Regulatory Consulting
- Site and Manufacturing Operations Consulting
- Supply Chain Support
- Owner’s Project Management
- Early and Mature Asset Management
- Asset Performance Optimization
- Work Management Services
- Automation and Information Technology Services