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Review and evaluation of data
packages prior to in licensing agreements
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Evaluation of preclinical work to date, providing estimates of cost to reach an IND and assisting in the search for funding
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Assistance in writing of grant proposals, SBIR
applications, RAID applications and others
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Evaluation of the GLP status of your laboratories, identifying deficiencies, providing
training in GLP principles for your staff, writing SOPs for your laboratory or
providing sample SOPs
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Scientific review of your program to date and development of a regulatory strategy
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Design of individual preclinical studies and preparation of protocols
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Assistance in
evaluating CROs, selecting a CRO, obtaining competitive bids, monitoring
the work and reviewing the final reports
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Writing or assistance in writing an IND, NDA, BLA or European expert report
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Evaluation of unusual and unexpected findings in safety studies, design of
mechanistic studies to elucidate and evaluate the significance of these findings
and/or preparation of position papers placing the findings in perspective
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Defense of study results or registration applications at the FDA, EPA or European
agencies, including preparation of review papers and interpretive reviews of
test results
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