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Product development
support
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Strategic
non-clinical program design
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Toxicology and
specialty study design
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Non-clinical
development plan preparation
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Non-clinical cost
estimating and budget preparation
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Project timeline
preparation
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Team meeting
facilitation
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Team communications
management
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Management of team
dynamics
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Risk management
planning
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Study protocol
preparation and review
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RFP preparation and
proposal review
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CRO evaluation and
selection
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Study monitoring
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Data interpretation
and integration
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Report preparation
and review
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REACH toxicity
summary preparation
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Coordination of
specialty services (pathology peer-review, clinical data
management, pharmaceutical sciences, quality assurance services,
etc.)
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Good Laboratory
Practices (GLP) compliance
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Toxicology written
and tabulated summary preparation for INDs/CTAs, Investigator
Brochures, Annual Reports/PSURs, and CTDs
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Experienced with
FDA, EPA FIFRA and TSCA, EMEA, OECD, Japanese MAFF, MOHW and
MITI, and other regulatory agencies
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Preparation of
Summaries of Toxicological Data for specific products (chemical
or pharmaceutical)
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Literature searching
and summary of public information for R&D programs
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Non-clinical due
diligence for in-license opportunities
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Specializing in
acute, subchronic, chronic, carcinogenicity, special,
developmental, reproductive and inhalation toxicology
