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FDA IND/NDA Drug & Biologic Regulatory

$150/hr Starting at $100

I provide complete support from preparing initial pre-IND packages and FDA meetings, to developing all modules of the IND for submission. I can support you as you develop your NDA or BLA to bring a drug or biologic product to market, including special pathways and designation requests that can speed your clinical development program.

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$150/hr Ongoing

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I provide complete support from preparing initial pre-IND packages and FDA meetings, to developing all modules of the IND for submission. I can support you as you develop your NDA or BLA to bring a drug or biologic product to market, including special pathways and designation requests that can speed your clinical development program.

Skills & Expertise

ClinicalClinical TrialsHealthMedicalPharmaceuticalsPharmacogeneticsPharmacokineticsProgram ManagementRegulatoryRegulatory AffairsStrategyVenture

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