SERVICES

Our PPM team has significant experience in assisting owners with the development of clean, compliant facilities and processes for companies around the globe. We have the proven ability to develop the design concept, the construction plan/components, and procurement strategy. This ability coupled with a deep understanding of financial analytics required to make projects a reality help us to produce successful projects for our clients. Many of our PPM team members have previously sat in the end-user chair and now are able to assist other firms, like yourself.

As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.

The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.

Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.

Having your commissioning agent (CxA) involved in the design phase brings value that is not realized until the project is finished. A CxA has been through many different configurations and knows what works, and what does not.

We set the industry standard when it comes to commissioning and qualification project delivery.

In your organization, there are constant challenges to streamline post-approval changes to meet market demand and prevent drug shortages. Critical to a streamlined process is robust process change management with targeted assessments giving you the desired outcome to reduce deviations, lower cost of quality, and enhance your regulatory strategy.