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Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp Industry Expert

At Registrar Corp, we are more than a company; we are a team of over 200 dedicated experts from diverse backgrounds including former FDA officials and seasoned industry specialists. Our mission has been to simplify the path to compliance for businesses around the globe.

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Background

Established in 2003, Registrar Corp has developed a reputation as the leader in global compliance, catering to industries including food and beverage, cosmetics, drugs, and medical devices. Our team leverages comprehensive tech-enabled services and deep regulatory knowledge to provide streamlined solutions that address the challenges of compliance across various sectors.

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40 Results
了解五种 DMF 类型：FDA 药物主文件指南

了解所有 5 种 FDA DMF 类型 — 如何使用它们、应避免什么以及如何将机密提交转化为战略监管资产。
通过战略药物主文件提交来保护您的监管未来

通过 FDA 就绪格式、生命周期策略和申办方协调来掌握 DMF 提交，以获得速度、信任和合规优势。
什么是药物主文件 （DMF）？ FDA 合规完整指南

了解如何提交、构建和维护符合 FDA 要求的药物主文件 （DMF），包括 eCTD 格式和全球区别。
为什么全球主文件在药物提交中很重要

将 FDA 药物主文件与 ASMF、CEP 和 J-DMF 等全球同等文件进行比较，以简化主要市场的监管提交。
药品注册：FDA 要求、职责和战略考虑因素 

了解 FDA 药物机构注册和上市规则、FEI 使用，以及如何根据 21 CFR 207 保持美国市场准入合规。
MoCRA 豁免：小企业需要知道什么

了解小型化妆品企业如何有资格获得 MoCRA 豁免，避免不必要的法规，并符合新的 FDA 化妆品法律。


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