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How We Work
SMAC is built to deliver senior, regulatory-grade work and to scale to the needs of a program.
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Senior-led engagements: every project is led by experienced scientists and regulatory professionals, backed by an established network of specialists.
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Quality and compliance: deliverables are prepared under defined processes to withstand agency, payer, and peer review, with confidential and regulatory data handled accordingly.
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Global reach: experience across FDA, EMA, MHRA, and other agencies, and across CLSI and EUCAST.
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Flexible engagement models: retained, project-based, or fractional, scoped to the asset and its stage.
How to Engage
Getting started is simple and does not require a formal RFP. A senior core team, backed by an established network of specialists, scales to the needs of your program.
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Scope: a short conversation to understand your asset, its stage, and where you need support.
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Proposal: a tailored scope of work and the engagement model that fits, whether retained, project-based, or fractional.
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Delivery: a senior-led team gets to work, integrated with yours, under confidentiality from day one.