卖什么
AI-Native FDA Regulatory Services
商业模式拆解
买家：谁掌握预算？
未核实Founder / regulatory affairs head at device or biotech companies
触发点：什么让他们现在购买？
Need faster, cheaper FDA approval across 510(k), De Novo, PMA, IND, NDA, BLA
工作流：什么输入变成什么输出？
Expert strategy and roadmap, pre-submission meetings through authoring and submission, accelerated by FDA-trained AI tools with expert oversight
经济账：省了什么，怎么收费？
Fixed milestone-based fees (pay when deliverables complete); claims 60% faster than traditional firms
渠道：怎么接触到客户？
Book a free consultation / call; customer stories
融资历史与报道
| 融资日期 | 轮次 | 金额 | 投资方 | 来源 |
|---|---|---|---|---|
| — | YC 2026 春季 | — | Y Combinator | ycombinator.com |
档案汇总自公开报道和公司官网。商业模式部分是 MaxBC 对这些材料的解读，不是已确认的事实；未知之处留空，不作猜测。 更新于 2026-10-12.