Asset Assessment Services
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Initial scientific evaluation of mechanism of action
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Cross-species therapeutic potential analysis
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Market opportunity assessment
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Preliminary regulatory pathway determination
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Development cost and timeline estimates
FDA CVM Services
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Pre-submission conferences
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NADA (New Animal Drug Application) preparation
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Technical sections management:
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Chemistry, Manufacturing, and Controls
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Safety (Target Animal Safety Studies - TASS)
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Effectiveness (Target Animal Effectiveness Studies - TAES)
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Environmental Impact
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Administrative NADA support
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Post-approval changes
Technical Package Review
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CMC data evaluation
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Safety and toxicology data review
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Clinical studies assessment
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Gap analysis for veterinary applications
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Formulation assessment for animal use
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CMC data evaluation
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Safety and toxicology data review
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Clinical studies assessment
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Gap analysis for veterinary applications
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Formulation assessment for animal use
Development Support
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Protocol design for TASS and TAES
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CRO selection and management
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Quality assurance oversight
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Data analysis and report preparation
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Response to FDA inquiries
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Protocol design for TASS and TAES
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CRO selection and management
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Quality assurance oversight
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Data analysis and report preparation
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Response to FDA inquiries
Strategic Planning
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Product development roadmap creation
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Resource requirement planning
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Timeline development
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Budget estimation
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Risk assessment and mitigation
Specialized Services
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Bioequivalence study design
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Pharmacokinetic/pharmacodynamic modeling
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Novel formulation development
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Dosage form optimization
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Stability testing strategy
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Manufacturing tech transfer
Contact
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