药品企业注册

所有生产预期用于疾病的诊断，治疗，症状缓解，处理或疾病的预防中有活性药物成分或其它直接作用，或能影响机体的功能和结构的药品工厂需要向FDA进行注册并申报其所有成分。非处方药OTC（例如：免洗洗手液，带有防晒功能的化妆品，含氟牙膏等）美国FDA要求其生产商、包装商和经销商进行FDA注册。

美国代理人

非美国公司必须指定美国代理与FDA进行联络，指定授权联络人与FDA通信。

孤儿药申请递交

孤儿药是指拟用于FDA第526节规定的罕见疾病或条件的药物。

证书

已经在美国FDA注册的公司，经常被其客户或供应商要求核准其美国FDA注册真实有效。

我们可以协助贵司出具FDA证书，用于侧面证明其注册在美国FDA真实有效。FDA官方从不颁发任何证书。

DMF备案

DMF 药物管理档案(Drug Master Files, DMF)是一份提交给美国FDA的保密文件，它提供了关于用于生产药物的原料、活性中间体及其设施、流程、包装及仓储等相关的信息。

药品标签审核

《食品、药品和化妆品法》（FD&C）和《公平包装和标签法》（FPLA）授权FDA管理化妆品标签。本规定旨在告知客户产品的预期用途、警告、成分、净含量以及制造商、包装商或经销商的信息。它们还保护客户免受危害，并禁止虚假或误导性信息。

Self-Indentification自认定工厂

FDA要求仿制药和仿制药原料药的工厂在每年的5月1日至6月1日期间，递交自我认定信息。

邓白氏号码申请

邓白氏号码（D-U-N-S® Number是Data Universal Numbering System的缩写）是一个独一无二的9位数字全球编码系统，被广泛应用于企业识别、商业信息的组织及整理。邓氏编码可以帮助您迅速获得独创的，丰富而且高质量的信息产品和服务。

自2010年起，FDA规定医疗器械及医药企业办理FDA注册时，必须先取得邓白氏号码（也称邓氏号码,DUNS号码）。后续食品企业也需要申请邓白氏号码。

如您需要，我们会免费帮您获得邓白氏号码。

Drug Registration and NDC listing

Both the domestic and foreign manufacturers and certain distributors that manufacture, prepare, propagate, compound or process drugs and intend to market in US are required to register the establishment by using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. FDA also requires the establishments renew the registration annually between October 1 and December 31 of each year.

D‑U‑N‑S Number

The Dun & Bradstreet D-U-N-S Number is a unique nine-digit identifier for businesses. Before register in FDA, the facility should get the D-U-N-S Number . We can assist with it for free.

Self-Indentification Facility-GDUFA

Contact us to find more information.

Drug Product Label Review

We helps drug customers to comply with FDA labeling regulations and assist with labeling preparation. The regulations are intended to inform the customers of the product's intended use, warning, ingredients, net quantity of contents, and information of manufacturer, packer or distributor. They also protect customers from hazards, and prohibit against false or misleading information.

Drug Master Files (DMF)

Drug companies can file a Drug Master File (DMF) in eCTD format to FDA, in order to keep their processing, material and facility confidential to the public. With the submission of DMF, the drug companies can authorize others to reference this DMF to support others' New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) without disclosing any information related to Intellectual property. RGLM consulting is proud to assist customers to prepare and submit DMF to FDA.

Drug Registration Certificate

BES consulting register your drug facility and provide you with our trusted Certificate of Registration.

ORPHAN DRUGS

Orphan drug means a drug intended for use in a rare disease or condition as defined in section 526 of the act.

Drug US Agent

The foreign establishment must appoint a United States agent (U.S. agent) during establishment registration.