Project Management
We provide senior project managers who can manage a variety of projects, from commissioning/ qualification, process and cleaning validation, PAT implementation, process improvement projects, compliance implementation, and construction management.

Maintenance Program Development
We understand both the business drivers and the regulatory drivers for a good preventive maintenance and calibration program.

We can rapidly and economically assess your firm’s maintenance programs, focusing on such critical areas as calibration, personnel training, quality assurance, and overall cGMP compliance. Following the assessment, we provide a detailed project plan with specific action steps to ensure reliable equipment operation, proper documentation of maintenance, and streamlined procedures. We take an integrated approach to maintenance. Our in-depth understanding of quality assurance and validation allows us to incorporate these key functions directly into your firm’s program.

We understand reliability centered maintenance as a strategy for formulating an optimum, cost-effective program that meets business and regulatory requirements.

SOPs and Training
Our technical staff is adept at developing technical procedures to support equipment operation, IT system administration, mechanical maintenance, and instrument calibration. We can also provide training on these procedures.