ProjectsProjects

项目制服务Project Services

非常规、一次性的专项合规事务：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.

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510(k) 全案Full 510(k) Submission

二类医疗器械上市前向 FDA 递交 510(k)，证明与已上市比对器械的实质等同。For Class II devices: premarket submission to FDA demonstrating substantial equivalence to a marketed predicate device.

路径判定与比对器械检索Pathway determination & predicate device search
测试计划与资料准备Testing plan & dossier preparation
递交、补件（AI）跟进到办结Submission & additional-information follow-up through clearance

如何收费：How it's priced: 评估后单独报价——每个产品的比对与测试范围不同，先评估再给书面分项报价。Quoted per project after evaluation — every product's predicate and testing scope differs; we scope first, then quote in writing, item by item.

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FCE + SIDFCE + SID

向美国出口低酸罐头食品（LACF）或酸化食品（AF）的强制要求。Mandatory for exporting low-acid canned foods (LACF) or acidified foods (AF) to the US.

FCE 食品罐头企业注册FCE (Food Canning Establishment) registration
SID 每个产品的工艺备案SID scheduled process filing per product
与食品设施注册的衔接Coordination with food facility registration

如何收费：How it's priced: 按企业与产品数量评估报价，工艺资料清单一次给全。Quoted by establishment and product count; the full process-document checklist provided up front.

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标签审核Label Review

FDA 进口抽查与市场检查的高频问题点，一次审全四类产品标签。A top trigger for FDA import exams and market inspections — one review covering all four product categories.

食品 / 膳食补充剂标签Food / dietary supplement labels
化妆品 MoCRA 标签Cosmetics (MoCRA) labels
医疗器械标签与 UDIMedical device labels & UDI
OTC / 药品 Drug Facts 标签OTC / drug Drug Facts labels

如何收费：How it's priced: 中英文逐项审核，出具问题清单与修改建议，按产品计费。Bilingual item-by-item review with an issue list and fix recommendations; priced per product.

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扣货 / 警告信应对Detention / Warning Letter Response

货物被 FDA 扣留、收到警告信或列入进口警报时，时间就是一切。When FDA detains your shipment, issues a warning letter, or places you on import alert — time is everything.

原因分析与应对策略Root-cause analysis & response strategy
英文回复函撰写与提交English response letters drafted & submitted
整改计划（CAPA）指导Corrective action (CAPA) plan guidance
进口警报移除申请支持Import alert removal petition support

如何收费：How it's priced: 按紧急程度与工作量评估报价；越早介入，解决成本越低。Quoted by urgency and workload; the earlier we engage, the lower the cost to resolve.

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UDI / GUDIDUDI / GUDID

医疗器械唯一标识实施：编码规则、标签加贴、GUDID 数据库提交。Medical device unique identification: coding rules, label application, GUDID database submissions.

UDI 编码方案设计UDI coding scheme design
GUDID 账户与数据提交GUDID account setup & data submission
标签切换计划Label transition planning

如何收费：How it's priced: 按产品型号数量评估报价。Quoted by number of product models.

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DMF 药物主文件Drug Master File (DMF)

API 等上游材料的主文件准备与提交，支持下游制剂客户引用。Master file preparation & submission for APIs and upstream materials, supporting downstream finished-product clients via letters of authorization.

DMF 类型判定（Type II 等）DMF type determination (Type II, etc.)
eCTD 格式资料准备eCTD-format dossier preparation
授权信（LOA）管理Letter of authorization (LOA) management

如何收费：How it's priced: 按 DMF 类型与资料完整度评估报价。Quoted by DMF type and dossier completeness.

我们的报价原则：Our quoting principle: 所有项目制服务都先评估、再给书面分项报价，明确包含内容与不包含内容；FDA 官费、测试费实报实销，不加价。项目范围不变时按书面报价执行。Every project is scoped first, then quoted in writing item by item — what's included and what's not; FDA official fees and testing costs are passed through at cost, no markup. The written quote applies as long as the project scope stays the same.

有个具体项目要处理？先发资料评估Have a Specific Project? Start With an Evaluation

描述你的情况并附上相关文件，我们评估后给书面方案与报价。Describe your situation with relevant documents, and we'll respond with a written plan and quote.

联系获取定制报价Get a Customized Quote