Hi there!
I am Raz Eliav, the founder of Beyond CMC, helping startups in Drug Development know what to do, how to do it, and when.
I do this by offering consulting services as well as professional training to teams.
My expertise revolve around the Regulatory-CMC aspects, including Manufacturing operations and CDMO management, CMC development support, as well as Regulatory strategy, meetings and submissions.
I have experience with a wide array of product modalities- from small molecules to Cell therapies (and many in-between), at all clinical development stages.
Consulting services
CMC and Regulatory Strategy,
and hands-on support to your team
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Establish and operate a phase-appropriate CMC development strategy
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Science and Risk-based CMC troubleshooting- accommodating the "right thing to do" with the Startup reality and constraints
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Assistance with CMC operations: CMO selection, Tech transfers, Process development studies, etc.
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Regulatory submissions and meetings- authoring, review and strategy
Dedicated CMC and RA Training
Beyond CMC offers a rich portfolio of CMC Training courses, which can be tailored to:
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Your team's needs,
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Your specific product modality
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Your stage of development (from Bench to Commercial)
Knoweldge Management and Digital Transformation
Establish an in-house practice of Knowledge management and /or initiate your digital transformation, as we step towards the Regulatory requirements of tomorrow.