Title 21 Quality System and Regulatory Compliance Consulting
Providing Title 21 Project Management, Quality Systems, Quality Assurance,
Regulatory Compliance, Validation, Training, and Auditing services.
Providing Title 21 Project Management, Quality Systems, Quality Assurance,
Regulatory Compliance, Validation, Training, and Auditing services.
Six Sigma and Lean Project Management Services 
Improving the quality of process outputs by identifying and removing causes of defects and minimizing variability in manufacturing and business processes.
Improving the quality of process outputs by identifying and removing causes of defects and minimizing variability in manufacturing and business processes.
Quality Systems Services 
Development and implementation of Modern Quality Systems, ensuring Quality by Design, Continual improvement, and Risk Management.
Development and implementation of Modern Quality Systems, ensuring Quality by Design, Continual improvement, and Risk Management.
Quality Assurance Services 
Development and implementation of effective systems for managing Quality, encompassing the organizational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that all products and/or processes will meet intended Quality and/or performance specification.
Development and implementation of effective systems for managing Quality, encompassing the organizational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that all products and/or processes will meet intended Quality and/or performance specification.
Regulatory Compliance Services 
Strategic planning of routine and for cause Regulatory activities. Pre and post licensing; inspection preparation, post inspection communication and mentoring, agency submissions and filings, remedial activities, recall efforts, annual reports and process/system modification plans.
Strategic planning of routine and for cause Regulatory activities. Pre and post licensing; inspection preparation, post inspection communication and mentoring, agency submissions and filings, remedial activities, recall efforts, annual reports and process/system modification plans.
Technical Services
Technical support including system configuration and planning, process design and development, specification development, creation of process standardization tools, problem investigation, corrective and preventative action determination and facility planning.
Technical support including system configuration and planning, process design and development, specification development, creation of process standardization tools, problem investigation, corrective and preventative action determination and facility planning.
Validation Services
Design and execution of facility, utility, and equipment qualification, process and automation validation projects. Programs designed to establish and document confidence in the ability of each component of a process, or the process itself.
Design and execution of facility, utility, and equipment qualification, process and automation validation projects. Programs designed to establish and document confidence in the ability of each component of a process, or the process itself.
