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食品和饮料
FDA注册和美国代理
Registrar Corp的注册代理服务包含
- FDA注册及年度更新
- MyFDA.com通道
- 免费的注册信息更新
- 每年三次免费预先申报
- FDA合规状态监控
- Registrar Corp签发的注册证书
- 扣货协助
- DUNS服务
- 非美国食品企业注册和美国代理$695美元（包括注册证书）
- 美国食品企业注册$195美元（包括注册证书）
- 注册证书$195
罐头食品工厂注册(FCE)和加工流程申报(SID)
Registrar Corp的FCE-SID部门的专家可以为罐头食品生产企业提供双语协助，包括：
- 罐头食品生产设施注册（FCE），包括如何操作FDA低酸酸化食品(LACF）办公室的在线注册系统。
- FCE-SID申报所要求的指标，格式，及其它特殊要求。
- 由Registrar Corp签发的FCE-SID证书记录您持有的有效SID申报资料，让您的客户确信您的产品已经通过美国FDA审核。
- FCE-SID 申报服务 (首年)：$1995
- FCE-SID申报服务(年度更新)：$995
- FCE-SID 豁免证书：$399/产品
食品接触材料(FCS)
一种食品接触材料受FDA哪些监管取决于其化学成分和预期用途。 Registrar Corp的法规专家团队可协助生厂商根据其具体产品判断根据其化学成分，而需要对应遵守的FDA发布和执行的规范和限制。
- 食品接触材料审核每个产品$1495
FDA Export Listing Module
Registrar Corp can properly petition to have your facility included on an FDA export list through FDA’s Export Listing Module.
- ELM PetitionContact Registrar Corp for Pricing
Guide to U.S. Wine Label Regulations
The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates wine with an alcohol content of 7% or more, and the labeling of these wines must be approved by TTB before marketing. Registrar Corp’s wine labeling guide will arm you with the knowledge you need to develop a compliant wine label.
- Wine Labeling Guide$195
State Bottled Water Requirements
Many U.S. states require licensing, certification, or additional labeling statements for bottled water sold in their jurisdiction in additon to FDA regulations. Registrar Corp offers reports that explain the different requirements for each state.
- State Bottled Water Guide$695
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
医疗器械
FDA注册和产品列名
Registrar Corp's U.S. Agent and Official Correspondent Services Include:
- FDA Registration and Renewal
- Certificate of Registration issued by Registrar Corp
- Registration Updates
- UDI Regulatory Contact
- Electronic Medical Device Reporting (eMDR)
- Detention Assistance
- FDA Compliance Monitoring of your facility
- 医疗器械FDA代理费用$995美元（年费）
包括官方联络人，美国代理，GUDID法规联系人和eMDR授权官员 - 注册证书$195
- 器械列名每个产品编码$195
一次性购买多个列名可提供折扣。
开始全球器械唯一标识数据库(GUDID)递交
Registrar Corp提供简捷高效、低成本的FDA UDI和GUDID法规解决方案。
- 单个递交$95
- 10个批量递交$495
- 25个批量递交$995
- 50个批量递交$1495
- 100个批量递交$1990
- 500个批量递交$7250
- 1000个批量递交$9950
医疗器械主文件(MAF)递交
Registrar Corp assists with Master File requirements. Our Regulatory Specialists can:
- File a new DMF, MAF, or VMF
- Update or Amend an MF
- Convert a paper DMF to eCTD
- MAF递交$1495
- MAF美国FDA代理$995 (年度费用)
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
药品
FDA注册和产品列名
Registrar Corp's U.S. Agent and Registrant Contact Services Include:
- FDA Registration and Renewal
- Certificate of Registration issued by Registrar Corp
- Annual Listing Certification
- Registration and Listing Updates
- Labeler Code Assistance
- Detention Assistance
- DUNS Assistance
- FDA Compliance Monitoring of your facility
- FDA药品企业注册$995（包括证书）
- 注册联系人和美国代理（非美企业）$995 (年度费用)
- 注册证书$195
- 药品列名每个$695
一次性购买多个列名可提供折扣。
开始递交药品主文件(DMF)
Registrar Corp assists with Master File requirements. Our Regulatory Specialists can:
- File a new DMF, MAF, or VMF
- Update or Amend an MF
- Convert a paper DMF to eCTD
- 递交DMF$1995 USD
- Non-CTD SubmissionContact Registrar Corp for pricing
- DMF 美国FDA代理$995 (年度费用)
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
化妆品
化妆品报告 (FDA或加利福尼亚州)
Registrar Corp可以协助确定贵司产品的成分是否在需递交报告的名录中，并且为贵司递交报告。
- 单个报告$695
- 10个批量报告$3950
- 25个批量报告$5625
- 50个批量报告$6250
- 100个批量报告$7500
同时向FDA和加利福尼亚州提交报告可提供折扣。
开始FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
膳食补充剂
FDA注册和美国代理
Registrar Corp的注册代理服务包含
- FDA注册及年度更新
- MyFDA.com通道
- 免费的注册信息更新
- 每年三次免费预先申报
- FDA合规状态监控
- Registrar Corp签发的注册证书
- 扣货协助
- DUNS服务
- 非美国食品企业注册和美国代理$695美元（包括注册证书）
- 美国食品企业注册$195美元（包括注册证书）
- 注册证书$195
膳食补充剂主生产记录
Registrar Corp的食品安全专家可以审核贵司的膳食补充剂主生产记录（MMRs）是否符合FDA的标准。
- First Master Manufacturing Record Review$2495
- Additional Master Manufacturing Record Reviews$1495 each
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
其它
标签和产品审核 (RED)
Registrar Corp审核辐射类电子产品的“标签”和放置，以确保其符合美国FDA广泛的辐射类电子产品性能标准、放置标准和标签法规，这些法规可能分布在近千页的《联邦法规》、《联邦公报》、指南性文件、标签指南和FDA签发的警告信里。
- 标签或产品审核Free Assessment
一次性购买多个产品审核可提供折扣。
开始FDA注册和美国代理
Registrar Corp helps tobacco manufacturers comply with FDA Regulations
- 代理$495
- 烟草制品企业注册$195
烟草制品企业注册 及产品注册费用
Registrar Corp helps tobacco manufacturers comply with FDA Regulations
- 单个递交$195
- 10个批量递交$1750
- 25个批量递交$3750
- 50个批量递交$6250
- 100个批量递交$9500
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
