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Mr.
Costas B. Chantzis, founder of our company, and John Donohue, each of them
have had an impressive and verifiable list of industrial accomplishments
for 26+ years (1980 to date.) Our expertise includes:
- Business/operational excellence, LEAN Six Sigma,
Baldrige business transformation, intellectual property and business due
diligence, research and development, technology transfer, process/system
improvement and remediation
- Strong communication and management skills
in empowering people to achieve “stretch” business objectives
- Remediation
plans development and implementation
- Leading edge knowledge in biomaterials,
material surface treatment, tribology, colloids, cutting tools, membranes,
powders, gels, fluid pumping and processing, aseptic filling, lyophilization,
sterilization and packaging
- Developed proprietary models/templates for
due diligence of business/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
- Thorough know-how in process
analytical technology, quality by design, quality function deployment, design
controls, system/component impact assessment, critical process parameters,
critical quality attributes, deviation investigation, CAPAs, quality risk
management, modeling, statistics, Six Sigma and Baldrige performance, lean
manufacturing quality and productivity tools
- Helped
such companies as Eli Lilly, Purdue Fredricks Laboratories, Johnson &
Johnson, Schering-Plough, Sharp (Pharma Contract Manufacturer), B. Braun,
Alcoa, Minolta, B. F. Goodrich, Kimberly Clark, Abbott Laboratories,
Medtronic, Cardinal, and numerous start-up ventures realize millions of
dollars in quantifiable benefits
Business Excellence
Services
Our Business
Excellence record includes:
Summary:
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Twenty-six years of experience in business / operational excellence, Six
Sigma, Baldrige business transformation, process/system improvement, validation, regulatory compliance,
intellectual property and business due diligence, research and development,
technology transfer, and remediation with an impressive and verifiable list of
accomplishments in pharmaceuticals, medical devices, and other industrial
sectors
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Have leading edge knowledge in biomaterials, material surface treatment,
tribology, colloids, cutting tools, membranes, powders, gels, fluid pumping and
processing, aseptic filling, lyophilization, sterilization and packaging
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Have developed proprietary 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
–
Have thorough know-how in process
analytical technology, quality by design, quality function deployment, design
controls, system/component impact assessment, critical process parameters,
critical quality attributes, deviation investigation, CAPAs, quality risk
management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige
performance, lean manufacturing quality and productivity tools
–
Have helped such companies as Eli Lilly, Purdue Fredricks Laboratories,
Johnson & Johnson, Schering-Plough, Sharp (Pharma. Contract Manufacturer),
B. Braun, Alcoa, Minolta, B. F. Goodrich, Kimberly Clark, Abbott Laboratories,
Medtronic, Cardinal, and numerous start-up ventures realize millions of dollars
in quantifiable benefits
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