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Mr.
Costas B. Chantzis, founder of our company, John Donohue and Barry
Graziano, each of them
have had an impressive and verifiable list of industrial accomplishments
for 26, 29 and 35 years, respectively, in the pharmaceutical, biotechnology, medical
device, life science, healthcare, diagnostics and other industries, being
experts in
business / operational excellence, Six
Sigma, Baldrige business transformation, continuous process improvement,
re-engineering, turnaround, validation, regulatory compliance,
intellectual property and business due diligence, research and development,
technology transfer, process/system improvement and remediation, models/templates for due diligence of
regulatory compliance and operational excellence comprising systems of quality,
facility and equipment, materials, production, packaging and labeling,
laboratory controls as well as intellectual property, product’s
commercialization phases, cost of quality, performance and productivity,
manufacturing plants, and business entities, biomaterials, material surface treatment,
tribology, colloids, cutting tools, membranes, powders, gels, fluid pumping and
processing, aseptic filling, lyophilization, sterilization and packaging, process
analytical technology, quality by design, quality function deployment, design
controls, system/component impact assessment, critical process parameters,
critical quality attributes, deviation investigation, corrective action and
preventative action (CAPAs), quality risk assessment, quality risk
management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige
performance, lean manufacturing quality and productivity tools, validation, regulatory compliance,
process/system improvement and remediation, regulatory compliance audits, remediation plans development and implementation,
templates for and development, execution, data analysis, and final report
development of ES/COMM./IQ/OQ/PQ/PkV protocols for facilities/utilities,
equipment, and computer systems (GxP and 21 CFR Part 11 regulations), process
analytical technology, quality by design, quality function deployment, design
controls, system/component impact assessment, critical process parameters,
critical quality attributes, deviation investigation, corrective action and
preventative action (CAPAs), quality risk assessment, quality risk
management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige
performance, lean manufacturing quality and productivity, models/templates for due diligence of regulatory
compliance and operational excellence comprising systems of quality, facility
and equipment, materials, production, packaging and labeling, laboratory
controls as well as intellectual property, product’s commercialization
phases, cost of quality, performance and productivity, manufacturing plants,
and business entities, biomaterials, material surface treatment, tribology,
colloids, cutting tools, membranes, powders, gels, fluid pumping and processing,
aseptic filling, lyophilization, sterilization and packaging, development and revision of standard operational procedures (SOPs) and
Validation Master Plans.
Feel free to download our company's brochure.
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