+ROI Regulatory Advisory

+ROI Regulatory Advisory

Biotechnology Research

Toronto, Ontario 4 followers

Clinical and Regulatory Advisory for Life Sciences

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About us

+ROI (Positive Return on Investment) is focused on accelerating the clinical and regulatory development of life-changing therapeutics for unmet clinical needs, particularly in the areas of novel medical technologies, combination drug-devices, and psychedelics. We work with hand-in-hand with the C-suite of our client companies to negotiate directly with FDA, Health Canada, and European regulatory bodies on critical regulatory aspects, particularly contributing directly to the design of pivotal clinical trials. We have obtained FDA Breakthrough Designations for several client company's technologies to date and helped bring numerous therapeutics to patients who desperately need them. At the end of the day, our positive return on investment is not simply financial, but always involves a meaningful positive impact on our fellow human beings.

Industry
Biotechnology Research
Company size
2-10 employees
Headquarters
Toronto, Ontario
Type
Privately Held
Founded
2023

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    +ROI Regulatory Advisory

    4 followers

    We're honored to play a small part in this life-changing work and humbled by the ancient traditions from which this plant medicine came

    View profile for Josh Hardman, graphic
    Josh Hardman

    Founder at Psychedelic Alpha - Commentary, Consultancy, Community for the psychedelics industry

    This Issue: Google co-founder Sergey Brin is placing a big bet on ibogaine startup Soneira Bio, but questions over the novelty of at least some of the company's patent claims loom large. Johnson & Johnson is seeking approval for its esketamine nasal spray, Spravato, as a monotherapy for treatment-resistant depression. A head-to-head trial led by Ishrat Husain has received a chunk of change from the Canadian Institutes of Health and Research. The study aims to speed up the resolution of one of the field’s key questions: What is the contribution of psychotherapy to the apparent therapeutic effects of psilocybin for depression? Plus other stories, as always. Link in the comments.

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