CONSULTANTS CAN HELP companies when they need to:
DRIVE PROCESS PERFORMANCE
In today's highly competitive industry environment, the ways in which business processes are designed and executed have become as important as the innovation of the products themselves. Achieving innovation and effectiveness in operational performance is based on an in-depth knowledge of GxP regulatory requirements and expectations; expertise in business strategy, process, and organizational design; and a belief in the following principles:
Companies are very much aware of their responsibilities to comply with these requirements. They are also aware of the cost of poor quality and its impact on the company's ability to achieve business goals and objectives. With this in mind, most companies have established quality-control systems and standards (e.g., policies, written procedures, training programs, etc.) that each relevant employee is required to adhere to.
A culture of quality is when people's beliefs, behaviors, and the infrastructure that supports them are driven by a shared commitment to do the right things right every time. Having quality at the core of business responsibilities and accountabilities is fundamental to providing safe products to the market.
LEVERAGING GLOBAL CAPABILITIES
Regulation and drug development throughout the world involves a substantial amount of detail. A consultancy's global capabilities and local knowledge acquired in a wide array of geographies is advantageous to the client who does not want to manage a team of independent service providers.
Parexel Consulting is a life sciences consultancy that helps companies design and execute biopharmaceutical and medical-device product strategies through a fusion of scientific, regulatory, and business expertise. It specializes in three main areas: clinical and manufacturing excellence, product development, and regulatory affairs. Parexel Consulting is a division of Parexel International.
Bruce Babbitt, a principal consultant with Parexel Consulting, can be reached at [email protected]
Peter Smith (not pictured) is vice president for pharma compliance. He can be reached at [email protected]