Preclinical Project Management
The two principals of DRUQUEST have extensive experience in subcontracting and managing safety testing programs. Dr. Kopplin managed the outsourcing at Cetus and then was responsible for outsourcing safety studies at Bristol-Myers Squibb (New Brunswick) Dr. Richter managed and monitored outsourcing of work for the Chevron Environmental Health Center as Coordinator of Pesticide Product Safety. Both of these principals have extensive experience working for CROs where they were responsible for the management and conduct of deveopment programs for large and small pharmaceutical and chemical companies from the U.S., Europe and Japan. Their eperience in outsourcing and as contractors makes them uniquely qualified to manage your drug or chemical deveopment program.
We are prepared to manage all or part of your preclinical safety protram. If you are a virtual company, we can be your preclinical department, becoming part of your develpment team.
The spectrum of our services includes:
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Evaluation of compounds for in-licensing
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Preparing development cost estimates
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Assistance in preparing summary documents to seek funding or a development partner
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Coordination of all activities with your staff incuding working with your clinical expers prior to the finalization of regulatory strategy and throughout the deveopment process
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Preparaton of briefing books for pre-IND meetings with the FDA
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Evaluation and recommendation of contract laboratories to conduct studies
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Preparation of protocols, initiation of studies, monitoring of the work and reviewing the resulting reports
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Design of special studies for test articles with unusual mechanisms of action or to elucidate the mechanism of action for an usexpected or unusual finding in sfety stdues
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Assistance in preparatiion of an IND or NDA, managing and coordinating the process for you
We woud be pleased to work with you on your drug development program.