FDA 注册与合规服务FDA Registration & Compliance Services
年费制注册维护与项目制专项服务，覆盖食品、化妆品、医疗器械、药品四大品类。所有服务均为定制报价——先评估你的产品，再给书面方案。Annual registration maintenance and project-based services across food, cosmetics, medical devices, and drugs. Every engagement is quoted custom — we evaluate your product first, then propose in writing.
注册 + 美国代理人 + 持续维护Registration + US Agent + Ongoing Maintenance
一年一签：当年注册申报、美国代理人服务、全年合规维护与续期提醒，打包省心。Annual engagement: registration filing, US Agent service, year-round compliance maintenance, and renewal reminders — one package, zero worry.
食品与膳食补充剂Food & Dietary Supplements
食品设施注册 / 续期、美国代理人、标签合规、膳食补充剂、FCE + SID。Food facility registration & renewal, US Agent, labeling compliance, dietary supplements, FCE + SID.
查看服务详情View details →化妆品 MoCRACosmetics · MoCRA
MoCRA 设施注册、产品列名、美国代理人、标签与成分合规。MoCRA facility registration, product listing, US Agent, labeling & ingredient compliance.
查看服务详情View details →医疗器械Medical Devices
一类 / 二类（510(k) 豁免）企业注册与产品列名、美国代理人、UDI / GUDID、510(k) 支持。Class I / Class II (510(k)-exempt) establishment registration & listing, US Agent, UDI / GUDID, 510(k) support.
查看服务详情View details →OTC 与药品OTC & Drugs
药品企业注册与药品列名、NDC、美国代理人、OTC 专论路径咨询。Drug establishment registration & listing, NDC, US Agent, OTC monograph pathway guidance.
查看服务详情View details →专项事务，单独评估报价Specialized Work, Scoped & Quoted Per Project
非常规、一次性的合规事务：先评估范围与难度，再给书面分项报价。Non-routine, one-off compliance matters: we scope the work first, then quote in writing, item by item.
510(k) 全案Full 510(k) Submission
评估后单独报价，按项目范围定制。Quoted per project after evaluation.
FCE + SIDFCE + SID
低酸 / 酸化罐头食品企业注册与工艺备案。Food Canning Establishment registration & process filing for low-acid / acidified foods.
标签审核Label Review
中英文标签逐项合规审查。Item-by-item bilingual label compliance review.
扣货 / 警告信应对Detention / Warning Letter Response
FDA 扣货、进口警报、警告信的专业应对。Professional response to FDA detentions, import alerts, and warning letters.
UDI / GUDIDUDI / GUDID
唯一器械标识实施与数据库提交。Unique Device Identification implementation & database submissions.
DMFDrug Master File
药物主文件（API 等）准备与提交。Drug Master File (e.g., API) preparation & submission.
先说说你的产品，我们再谈方案Tell Us About Your Product First
品类判定对了，后面每一步才不会走弯路。咨询免费，报价书面定制。Get the category right, and every step after is smooth. Free consultation, written customized quotes.