Core Services (flat fees, no hidden costs or change orders)
Start Up Projects
FIH Study Enabling Development Plan
starting at 25K USD
Nonclinical development plans from discovery to Phase I.
Clinical Development Plan
starting at 35K USD
Development plan encompassing Phase I to III including NDA/NDS/MAA, reimbursement, medical affairs, and other commercial launch considerations.
Nonclinical and Clinical Development Plan
starting at 50K USD
Comprehensive development plan starting with discovery through to Phase III including key NDA/NDS/MAA, reimbursement, medical affairs, and other commercial launch considerations
Investor Deck Scientific Sections
starting at 15K USD
Strategically designed scientific sections of a typical investor deck including product rationale, MOA, outline of development plans, nonclinical/clinical strategy etc.
Early Phase Projects
FIH Study Data Gap Analysis
starting at 5K USD
Critical review of existing data to identify gaps and risks to approval, wtih mitigation strategies, for a FIH study to be conducted in any ICH region.
IND Module 2/IB Authoring and/or Review
starting at 10K USD
Authoring and/or critical review of FIH study Module 2 summaries and/or the IB to ensure strategic messaging is maintained, data requirements are met, gaps are justified, and risks are mitigated.
Critical Analysis of Regulator Feedback with Response Writing, if required
starting at $400 USD
Expert critical analysis, review, and interpretation of regulator feedback with a summary of recommendations for next steps.
Chemistry, Manufacturing, and Controls (CMC)
GMP Manufacturing Strategy Plan
starting at 7.5K USD
Critical review of existing CMC data and plans to develop a strategy for ensuring GMP readiness for clinical batches.
IND/CTA Module 2 Quality Overall Summary Review and/or Authoring
starting at 15K USD
Authoring and/or critical review of FIH study Module 2 QOS to ensure phase appropriate requirements have been met and/or gaps and risks are identifed with mitigation strategies.
Critical Analysis of Regulator Feedback with Response Writing, if required
starting at $400 USD
Critical analysis, review, and interpretation of regulator CMC feedback with a summary of recommendations for next steps
Interim Staffing Solutions
Head of RA
customized based on needs
Associates
customized based on needs
Ad Hoc
General Consulting
$200 USD/hr
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