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Nonclinical Drug Development and Safety Evaluation

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  Services
 

 
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Assist with assay development, conduct, and interpretation during lead optimization 

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Conduct literature searches and summarize data pertinent to research/development programs

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Perform nonclinical due diligence for potential inlicensed programs 

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Provide a comprehensive nonclinical IND-enabling plan for small molecule or biopharmaceutical programs

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Provide team leadership and project management for the nonclinical aspects of drug development programs 

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Identify cost-effective toxicology contract research organizations (CROs) for nonclinical Tox/Pharm/ADME studies, write protocols, monitor study conduct, ensure GLP compliance and deliver quality data and reports

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Write the nonclinical sections of INDs and marketing applications 

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Provide nonclinical regulatory advice, and represent the client at regulatory agency meetings and telecons, respond to any nonclinical regulatory issues 

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Identify and convene scientific experts, and other drug development consultants, when needed 

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Write regulatory agency submission quality reports with data provided from the client’s lab or a CRO 

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Write publication quality manuscripts for research and development  

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Conduct on site training and/or seminars on nonclinical drug development

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