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PHARMACEUTICAL |
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From time to time, the complexity of projects results in an unreasonable workload for
you and your staff. That's when outsourcing to a highly qualified analytical laboratory
and scientific support company makes sense. CPS can help you and your team in the following areas: |
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| CMC REGULATORY CONSULTING/DOCUMENTATION
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• Technical data review
• Document preparation for: |
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IND plus amendments for each clinical phase |
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NDA |
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MAA |
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CTD |
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ANDA |
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eCTD |
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• Coordinate the writing/document-production team during preparation of a complete package ready for submission |
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| ANALYTICAL |
| Instruments |
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LC/DAD |
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LC/MS/MS |
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Method development in a variety of matrices |
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Method adaptation |
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Method Validation |
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Routine analysis at all levels, even trace |
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GLP STUDY ASSISTANCE
• Technical writers
• GLP auditors
• Contract management assistance, from lab selection through contract
closure |
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Call us today for further information on how CPS can meet your needs! |
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