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Pharmaceutical
Drug Development
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Among
the many disciplines involved in Drug Development, I can assist you
in the following areas: |
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Test
Method (Assay) Development |
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Choice
and design of test methods, preparation and/or review of written methods
(SOP), validation, troubleshooting, QC transfer. |
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Quality
Control |
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Assay
transfer, SOPs, stability study design, data analysis, reports for
IND or NDA submissions. |
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Manufacturing |
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Process
development, validation, GMP manufacturing documents, specifications,
reports for IND or NDA submissions. |
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Formulation
Development |
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Parenteral
and oral liquids, design for stability, clinically proven and accepted
excipients, manufacturability, bio-compatibility, development reports
for IND and NDA submissions. |
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