Services Offered
Strategic leadership and management of:
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Writing and defense of regulatory submissions to US, Canada, Europe and Asia |
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Meetings with regulatory agencies (scientific advice, preIND, end of PII/PIII, preNDA) |
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Drug substance process development and manufacturing |
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Dosage form development and manufacturing |
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Analytical development and quality control |
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Development of quality specifications |
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Validation of manufacturing processes and analytical methods |
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Business development discussions |
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Due diligence activities |
