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You
can trust our regulatory compliance, 483s, Warning Letters, Consent
Decree consultants/Experts to help you:
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Identify
compliance gaps by auditing your quality system against FDA
GXPs and current industry practices.
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Identify
bottom line quality and cost improvement opportunities by
proper process control implementation, elimination of waste,
non-value-added activities as well as product, process and
system non-conformities.
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Develop
and implement fast a cost-effective corrective action/
remediation plan that would satisfy your regulatory
requirements by preventing regulatory sanctions and ensuring
that your supply chain continues to produce your revenue stream
that are essential to maintain and grow your business.
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Develop
a proactive regulatory compliance system by identifying and
eliminating systemic regulatory compliance issues
in the most cost-effective way.
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Design
and implement effective compliant and operations-efficient
quality systems that integrate seamlessly with your present
and future business.
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Achieve
and then maintain a proper readiness state for FDA inspections
by intimately understanding the "process" and
communicating effectively with the FDA and other governmental
agencies.
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Achieve
regulatory remediation competence in knowing
how to manage possible FDA483's, Warning Letters and Consent
Decrees for enforcement intervention and
mitigation/remediation by developing and implementing
practical plans.
Our practical knowledge and extensive experience in the
medical device, pharmaceutical, biotechnology and related industries
enable us to efficiently help clients manage regulatory compliance
risk for optimal outcomes. We identify non-compliant areas, assess
risk, likelihood and potential impact of losses that would result
from non-compliance, and develop solutions, guidance, and training
to minimize the likelihood of such losses. Our compliance consulting
services is based on our extensive knowledge of the pharmaceutical
industry and regulatory requirements, and our experience in
identifying and delivering effective and regulatory-compliant
solutions. Our broad experience includes the performance of
regulatory consulting services for numerous clients that include
pharmaceutical companies, biotechnology firms, medical device
companies, injection molding manufacturers, third party contract
manufacturers, and related industries.
We perform detailed Regulatory Compliance Assessments / Due
diligence of pharmaceutical, biotechnology, and medical device
companies, and other third party contract manufacturers to determine
the regulatory compliance of systems, procedures, documentation, and
controls. We have a standardized and highly successful process that
consists of interviewing key users, developers, quality assurance,
support, and operation and management personnel who are involved
with the respective computerized system(s) and processes. We also
perform detailed assessments of the regulatory compliance of system
documentation, study records, and relevant information consistent
with regulations, guidelines, and expectations.
Our Regulatory Compliance Assessments and Vendor Audits
typically result in numerous findings and recommendations for
remediation that impact positively your business' bottom line. Our
proprietary methodologies and templates assure the comprehensive and
thorough completion of the identified remediation sub-projects and
related activities. Our consultants have assisted both sponsors and
vendors in assuring that all regulatory compliance issues are
adequately resolved through a structured process of planning,
progress monitoring, and reporting.
We
have performed numerous audits of vendors of medical device and
pharmaceutical products, contract service companies, technology
service providers, and data management organizations on behalf of
our domestic and global pharmaceutical, biotechnology, and contract
manufacturing clients. The audits were performed to determine the
level of compliance with local regulations and guidance regarding
computer system validation, GLP/GCP/GMP requirements, and 21 CFR
Part 11, and to minimize business and technical risks to the
purchaser. These audits are formally documented in Vendor Audit
Reports with reference to the relevant regulations and guidance, and
include extensive and detailed recommendations for corrective
action.
Our Regulatory Compliance Consulting Services include
general Quality Management and Compliance Consulting to assist
companies with the development or improvement of quality assurance,
quality control, and quality management processes, procedures, and
controls. Our trained and experienced consultants can provide expert
reviews of validation strategies, development methodologies, company
policies, procedures, and techniques. We can either provide our
recommendations in a formal report that provides strategic and
tactical improvements in policies, procedures, and documentation, or
our trained personnel can write missing or deficient quality
management documents.
Our
regulatory compliance, FDA consultants, experts help you know how to
react properly and deal with the agency, with your management and
your customers. We help you to know how to conduct yourself
and lift the cloud of regulatory sanction(s) and returning
"freedom to operate" to the company without breaking any
rules.
We
have led numerous remediation teams as part of larger consent
decree, warning letters of multiple 483 challenges. We have helped mentor clients'
personnel, evaluate/ investigate
manufacturing process deviations, identify root cause analysis
and implement appropriate and effective corrective and
preventive actions (CAPAs.)
Mr.
Costas B. Chantzis, founder of our company, has had an impressive and verifiable list of industrial accomplishments
for 28 years (1980 to date) in Regulatory Compliance projects. Our expertise
includes:
- Validation, regulatory compliance,
technology transfer, 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)
- Experienced in development and revision of
standard operational procedures (SOPs) and Validation Master Plans
- 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 regulatory compliance comprising systems of quality,
facility and equipment, materials, production, packaging and labeling,
laboratory controls
- 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
- Completed
successfully numerous technical due diligence regulatory compliance projects
(consent decree, 483's and/or warning letters, etc.) for Abbott
Laboratories, Eli Lilly, Purdue Fredricks Laboratories, B. Braun, Schering
Plough and many smaller size companies
- 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 meet their regulatory
compliance and overall business objectives ...
Costas
Chantzis has had 28 years of experience in the medical device,
pharmaceutical and biotechnology industries in the areas of
R&D, engineering, manufacturing, supply chain, quality
engineering, control, and assurance, corporate/operations, and
information technology. He gained entrepreneurial experience from
building his own consulting services firm specializing in the
implementation, compliance and validation of highly complex,
configurable business systems. Costas has consulted for various
national and international pharmaceutical, medical device, and
biotechnology companies and is internationally recognized for his
subject matter knowledge concerning regulatory compliance, quality
systems, and computerized system validation. Costas Chantzis has
consulted for various national and international pharmaceutical,
medical device and biotechnology companies and is internationally
recognized for his subject matter knowledge concerning regulatory
compliance, quality systems, and computerized system validation.
Costas Chantzis has demonstrated domestic and international
regulatory compliance experience including EMEA, FDA, GCP/PV, GxP,
HC, ICH, ISO, MHLW, 21 CFR Part 11, etc. compliance and audit
experience (submissions, annual audits, licensing inspections,
product meetings) and 483/Warning Letter/Consent Decree response
& remediation program development. Costas Chantzis specializes
in regulated
manufacturing, quality systems, computer system compliance and
validation, implementation and validation of R&D, ERP, MES,
EQM systems, FDA audit (annual audits, licensing inspections &
product meetings) and 483/warning letter/Consent Decree response
& remediation program development.
Regulatory Compliance
Services
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