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Ask Us About Our
FREE Analysis of Your Material and/or Manufacturing Process Problem
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Pharmaceutical Consultant, Regulatory
Compliance Consultant, Pharmaceutical Quality Assurance Expert, Quality
Control Consultant, Regulatory Compliance Consultant, Product Development
Consultant, Due Diligence Audit, Investigation, Expert, Engineering, Consulting,
Services, Validation Study Consultant, Specialist, Investigation,
Expert, Engineering, Consulting, Services
Expertise in quality control, quality
assurance and regulatory affairs, medical products businesses, chemistry,
manufacturing and controls (CMC) section of drug master files, DMFs, analytical
methods and process plans, protocols and reports, form FDA 483 and warning
letter responses, corrective and preventive action plans, training, general cGMP, general validation, and test method validation, negotiations with
regulatory agencies, customers, distributors and internal group, data analysis
including specification development and rationalization, trend analysis,
expiration and retest date justification, test method characterization
and validation, site qualification processes, product design validation
documentation, test method validation document evaluation, data traceability
audits, manufacturing process validation master plans, new product development,
planned discontinuance of out-dated products, NDA pre-approval inspections,
corrective actions, responses and re-inspection, chemical manufacturing
processes, good manufacturing practice (cGMP), total quality management
and ISO 9001 registration processes, in vitro diagnostic reagent, instrument
design control and quality control. Expertise in pharmaceutical
quality assurance, quality control, project management, regulatory affairs,
product development, management, 26 years experience in product development,
process development, validation, large scale manufacturing facility validation
and startup, process development, validation, production management, quality
assurance, quality control of FDA licensed biotechnology, small molecule
and device products, regulatory experience, GMP audit, regulatory compliance,
quality system development, validation, document control, laboratory management,
facility environmental monitoring, internal compliance and auditing, process
validation, microbiologic and chemical testing of materials and finished
product, product stability, plant EM, product test and release programs,
stability programs, instrument validation, and cleaning validation programs,
statistical process control based production planning, QC laboratory management,
drugs, ointments, creams, tablets, aseptic processing, powders, dissolution
rate, deformulation, remediation, significant investigations, variances,
protocol deviations, preventative actions, corrective actions 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
Give us your problem and we will
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Ask for Our 100% Satisfaction GUARANTEE
Mission: We exist to help clients achieve breakthrough
results by resolving complex technical and business problems that others
might have considered unsolvable.
Approach: Our problem solving methods uncover new opportunities
for clients and deliver novel solutions with bottom line benefits and a
competitive advantage. We commit to:
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Comprehend the regulatory, technology
and business issues of each industry served.
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Proactively develop effective solutions
for complex problems.
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Deliver added value quality and profitability results.
Our Competitive Edge: We have an
innate ability
to permanently resolve complex technical and business problems that others
might have
considered unsolvable. We have a genius to do what others can't. Our track
record of impressive and verifiable industrial accomplishments in the
medical device, pharmaceutical, biotechnology, life science, healthcare and
industrial goods markets is beyond a reasonable doubt evidence. Check it out
here or
ask to speak with anyone of them. You will be happy you did!
Why You should Give Us A chance? It
is true, lots of people get laid-off and become INSTANTLY consultants! Then,
these fly-by-night consultants charge deceptively cheap rates but do
what they did before - which is - NOTHING!!! So, not only these companies
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they waste priceless time and throw away much needed money. In contrast, you
and any other fact-finder will conclude that the following medical device,
pharmaceutical, biotechnology, healthcare, life sciences, industrial goods evidence
is beyond a reasonable doubt proof why you should give us a chance to
"show you" what we could do for you:
- Costas B. Chantzis, John Donohue
and Barry Graziano are your tried, tested and proven consultants
and experts because they have 27, 29 and 35 years, respectively, of
impressive and verifiable industrial accomplishments in the medical
device, pharmaceutical, biotechnology, life science, healthcare and
industrial goods markets. Check it out here
or ask to speak with anyone of them. You got nothing to loose BUT lots
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- These seasoned, accomplished,
results-oriented consultants will work on your project and make sure it
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unjustifiable consulting fees typically assign some kids or junior
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completing your project on time/within budget thereby putting it even
further behind-schedule with all the detrimental consequences to
your business. Meanwhile, these type of boutique consulting companies typically
have
one of their highly-paid, heavyweight consultants come-in
once-in-a-while to your company to make sure you don't kick them out
before they bleed your budget. Unfortunately, this scenario is not fictitious
but taken out of our real life experiences for the last 30 years in this
business.
- We are probably the ONLY consulting
company that GUARANTEES your 100% satisfaction. Please see below more
about this protection for you and your budget.
Deliverables: High quality services
to YOUR satisfaction with integrity and trust!
Our 100% Satisfaction GUARANTEE:
Here?s where the rubber hits the road: If you work with us and for any reason you are not satisfied with
our service, we will fully refund your fees (except pre-approved by you
project incurred expenses)!
That?s right. We will do everything in
our power to help you get where you want to go. We have an excellent track record or
we wouldn?t be making you this guarantee, I?m so sure that we can do an extraordinary job for you I GUARANTEE IT! No other
consulting company makes you this offer. Contact us today at (908)
827-1715 to get your project started, moving again, done or get your problem
permanently resolved.
We will partner with you for your personal and company's success.
I am sure you know that a good consultant can get the job done and a poor selection could make things worse.
Feel free to download our company's brochure.
Contact us today at 908-827-1715, we look forward to working with you.
Your partner in success!
Costas B. Chantzis, Founder and President
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