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SERVICES
Consultant/contractor
services include:
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Strategic guidance and
support to emerging companies
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Planning for lead
selection and backup strategy
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IND/registration
planning, preparation, and regulatory interaction
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Establish time and
cost efficient development programs
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Study design, lab
selection, oversight, data interpretation, and
reporting
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Regulatory document
preparation including 505(b)(2) submissions
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Guidance regarding
formulation excipients, API impurities, device
materials, and extractables and leachables
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Provide expert opinion
to support first dose for human studies
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Develop action plans
to deal with significant safety issues
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Evaluation of
nonclinical data for in licensing opportunities
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Executive team support
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