Harris Group has developed a professional staff with an extensive knowledge of regulatory requirements. Our in-house cGMP expertise ensures that your project will meet or exceed all applicable regulatory requirements for process validation including production equipment, piping design and layout, materials construction, movement of materials and personnel, control of environmental conditions, clean in-place and sanitation systems, and critical utilities such as purified water, clean steam, and air. We also support our customers with assistance in quality assurance programs and documentation in support of FDA and EU submissions.

From conception and detailed design to commissioning and operations management, Harris Group’s team members have completed over 20 Vivarium and BSL-2 & 3 laboratories for universities, private companies and state agencies. Our integrated team of architects and engineers has worked as client and design consultant in the development of these highly technical environments, providing a deeper understanding of the design and operational requirements.