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| Targeted cGMP
Implementation |
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The cGMP Implementation team at CBR
International Corp. specializes in efficient and cost-effective
development of Quality Systems and documentation to support
your cGMP compliance efforts.
CBR International can provide comprehensive “gap”
analyses and assist your company in drafting cost-effective
plans to implement successful cGMP quality programs and procedures
appropriate for the stage of development of each of your products.
With former FDA reviewers and investigators on our staff,
we are skilled auditors who can effectively prepare your company
for inspections by regulatory officials.
The compliance professionals at CBR International offer expert
guidance for all your manufacturing process and analytical
method validation requirements. We have practical experience
in preparing master validation plans, writing and executing
validation protocols, evaluating data, and writing validation
reports as well as providing essential services in the areas
of technology transfer and comparability protocol design.
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 e-mail at
info@cbrintl.com".
Technology
Transfer • Comparability Protocols • GAP Analysis
• Quality Systems Development • FDA-Style Mock
Audits • 21 CFR Part 11 Consulting • Quality
Systems Implementation • cGMP Training • Quality
Systems Audits • Train-the-Trainer Programs •
Protocol Development • SOP Writing • Validation
Protocol Development • Strategic Regulatory Documents
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