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Systems Integration |
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CBR International Corp. specializes
in the development of comprehensive Quality Systems that will
unite your entire organization under an “umbrella of
quality”, thus allowing your company to meet and exceed
the expectations of regulatory agencies.
Whether your organization is at the start of the drug, biologic
or device development process, or has multiple product lines
on the market, CBR International can work with you to meet
compliance standards while getting the most value from your
quality system. The foundation of any quality system is a
thorough knowledge of regulations. However, without an understanding
of the product and the organizational objectives, a poorly
designed quality system can encumber the entire process of
development. Our CBR team works with your management, scientists,
and quality staff to ensure that your system meets your objectives.
Writing and review of Quality Assurance and Quality Control
documentation, Certificates of Analysis, analytical and validation
plans, and facility and infrastructure analysis are a sampling
of the knowledge that we can bring to your organization.
CBR International has extensive experience in design, implementation,
review, gap analysis and auditing of quality systems for the
medical device, drug and biologics industries. We have assisted
large drug companies, device manufacturers, startup biotech
firms, and non-profit organizations to develop quality systems
that work.
Specific Consulting and Development
Experience
Consistent, thorough and up-to-date analysis of your evolving
needs is just the beginning of our commitment to your program.
For a comprehensive assessment of your program requirements,
please contact us by calling (720) 746-1190 or by email at
info@cbrintl.com.
Quality
Systems Development • Analytical Methods Development
• SOP Writing • Technical Writing • Quality
Systems Implementation • Systems GAP Analysis •
Scientific Writing • Quality Systems Audits •
Quality GAP Analysis • Quality Assurance Documentation
• Facility Analysis • FDA-Style Mock Audits
• Strategic Regulatory Documentation |
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