关于 GlobalRegAbout GlobalReg
一支位于美国的 FDA 合规咨询团队，帮中国企业把产品合规地送进美国市场。A US-based FDA compliance consulting team helping Chinese companies bring products into the US market — compliantly.
我们是谁Who We Are
GlobalReg 是一支位于美国马里兰州的 FDA 合规咨询团队。我们专注一件事：帮助美国境外的企业——尤其是中国企业——完成 FDA 注册、指定美国代理人，并在进入美国市场后持续保持合规。GlobalReg is a US-based FDA compliance consulting team in Maryland. We focus on one thing: helping foreign companies — especially Chinese companies — complete FDA registration, designate a US Agent, and stay compliant after entering the US market.
我们每天打交道的是 FDA 的四个主要监管品类：食品（含膳食补充剂）、化妆品、医疗器械、药品（含 OTC）。从品类判定、注册申报，到续期维护、扣货警告信应对，我们提供全周期的中文服务。We work daily across FDA's four major regulated categories: food (including dietary supplements), cosmetics, medical devices, and drugs (including OTC). From category determination and registration filings to renewal maintenance and detention / warning letter response, we provide full-cycle service in Chinese.
我们的理念What We Stand For
人在美国In the US, for real
递交、跟进、收 FDA 函件，都在美国本土完成——和 FDA 同一个时区，不让时差耽误你的货。Filing, follow-up, and FDA correspondence all happen inside the US — same time zone as FDA, so time differences never hold up your shipments.
说人话Plain language
法规条文翻译成你能听懂的中文：要做什么、为什么做、不做有什么后果，一条条讲清楚。Regulations translated into Chinese you can actually understand: what to do, why, and what happens if you don't — explained item by item.
先判定，再动手Determine first, act second
品类判错，后面全错。我们的咨询永远从“你的产品到底归哪管”开始，免费。A wrong category means everything after is wrong. Our consultation always starts with “which regulation actually governs your product” — free of charge.
长期主义Long-term thinking
注册只是一次，合规是每年。我们做年费制的持续维护，陪你走过每一次续期与法规变化。Registration happens once; compliance is every year. Our annual maintenance walks with you through each renewal and regulatory change.
我们坚持不做的事What We Won't Do
- ✓不承诺“包过”“加急”——审批权在 FDA，承诺包过的是骗子。We never promise “guaranteed approval” or “expedited review” — the decision rests with FDA; anyone promising approval is lying.
- ✓不混淆“注册”与“认证/批准”——这是两回事，签约前一定讲清楚。We never confuse “registration” with “certification / approval” — they are different things, and we make that clear before you sign.
- ✓不在官网挂完整价目表——每个项目范围不同，评估后书面定制报价。We don't post a full price list — every project differs in scope; we quote custom in writing after evaluation.
- ✓不接做不了的业务——超出能力范围的，直接说明并建议替代路径。We don't take work we can't do well — if it's outside our scope, we say so and suggest alternatives.
- ✓不泄露客户资料——你的产品与商业信息，仅用于为你服务。We never disclose client information — your products and business details are used only to serve you.
联系方式Contact
咨询、报价、合作，欢迎直接邮件联系（中文 / English 均可）：For inquiries, quotes, and partnerships, reach us directly by email (Chinese / English both welcome):
GlobalReg
North Bethesda, MD, USA
contact@globalregular.com
想聊聊你的产品？先从一次免费咨询开始Want to Talk About Your Product? Start Free
告诉我们你的产品与目标，我们帮你判定品类与路径。Tell us about your product and goals; we'll map the category and pathway.