解决方案

for Domestic Clients

Globalization

for Overseas Clients

Filing in China

1. 提供法规和技术支持，向外方提供申报资料编写大纲，指导外方准备必须的技术文件和证明性文件，保证向NMPA提供符合要求的申报资料。
2. 审核外方提供的资料文件，按照NMPA新要求提出审核意见，保证技术上符合NMPA要求。
3. 对外方提供申报资料进行差距分析，预估风险，提供补正措施，减少发补风险。
4. 翻译并撰写全套资料。
5. 如外方需要，针对申报资料中的缺陷，我方可以提供合同定制试验服务，以协助外方顺利通过技术审评。
6. 如涉及临床试验，协助并代理督查在中国开展的临床试验。
7. 全权负责与NMPA的沟通交流。
8. 申报资料提交后，后续的注册代理人服务，例如：注册检验及现场核查、提交年度报告、发补意见的解决方案、临床试验登记、DSUR提交等等。

We provide specialized registration services for overseas specialty FDFs and APIs seeking entry into the Chinese market.

Our approach encompasses a detailed gap analysis of application materials, risk assessment for potential supplements, and guidance on documentation preparation. We also manage the translation, review, finalization, and submission of all documents.

Our team meticulously track the registration progress, ensuring effective handling of all follow-up responses until filing approval is secured. In addition, we are responsible for the ongoing management of annual reporting and registration maintenance, safeguarding compliance throughout the product’s lifecycle in China.

Our Step-by-Step Approach to Filing

Plan

> Gap and SWOT analyses
> Risk management plans
> Global registration strategy and market analysis

Analyze and Interpret

> CTD/marketing authorization dossier drafting and translation
> Prepare DMF/ASMF/CEP/ANDA application documents in
eCTD format
> Data and document compliance

File

> Document publishing
> Delivery of dossier to health authorities

Manage Post-Filing

> Regulatory inquiry management from rapid response team
> Dossier lifecycle management

for Domestic Pharma Companies

Enhance Global Reach

Our primary goal is to match Chinese manufacturers with specialty patents with suitable overseas pharmaceutical companies. Through the process of licensing these patents to international partners, we aim to enable the patent recipients to carry out production and distribution, thereby fostering a deeper level of cooperation within the industry.

This strategic approach not only facilitates the transfer of valuable technical assets, but also promotes collaboration between Chinese innovators and international pharmaceutical companies. By leveraging our expertise in strategic licensing and our extensive network, we aim to drive innovation and create mutually beneficial opportunities for all parties.

for Overseas Pharma Companies

Unlock New Horizon

We are committed to addressing unmet clinical needs in China by introducing advanced formulations from global pharmaceutical companies. Through strategic licensing and meticulous planning, we enable our international partners to expand their reach, deepen their market presence, and bring innovative therapies to Chinese patients, fostering mutual prosperity.

Our key focus areas include:

  • Specialty Formulations
    • Combined Preparations
    • Improved Dosage Forms
  • New Drug Development
for Domestic Manufacturers

cGMP Consulting

We offer comprehensive cGMP support to prepare manufacturers for supplier audits and official inspections, including:

  • Gap Analyses
  • Improvement Strategies
  • Pre-Inspection Preparation & Mock Audit
  • Official Inspection Interpretation (EN/JP)
  • CAPA Responses
for Overseas Clients

Third-Party Audits

We offer expert on-site audits to assist remote suppliers in conducting qualifications and routine audits for manufacturers, featuring the following strengths:

  • Profound Insight into the Chinese Pharma Industry
  • cGMP Expertise in a Global Context
  • Well-Established and Rich Audit Background
  • Risk-Based Audit Planning
  • Thorough Reporting with Proactive Follow-Up

Chinese pharmaceutical companies with rich production experience and intention in developing Thailand as well as international market invest in building factories with Thai companies, grafting our technology and products onto Thai companies, so that the produced products in Thailand can not only promote in ASEAN market, but also can promote in European, American, Japanese, and Korean markets.

药政注册与产品代理

产品代理：与国内有出口法规市场经验的药企合作，独家代理一个 或多个已在欧美日完成注册的产品，共同完成在泰国市场的注册申报，进口和销售。

进口药品注册

针对以上业务，注册代理机构服务内容包括：
　　1. 提供法规和技术支持，向外方提供申报资料编写大纲，指导外方准备必须的技术文件和证明性文件，保证向NMPA提供符合要求的申报资料。
　　2. 审核外方提供的资料文件，按照NMPA新要求提出审核意见，保证技术上符合NMPA要求。
　　3. 对外方提供申报资料进行差距分析，预估风险，提供补正措施，减少发补风险。
　　4. 翻译并撰写全套资料。
　　5. 如外方需要，针对申报资料中的缺陷，我方可以提供合同定制试验服务，以协助外方顺利通过技术审评。
　　6. 如涉及临床试验，协助并代理督查在中国开展的临床试验。
　　7. 全权负责与NMPA的沟通交流。
　　8. 申报资料提交后，后续的注册代理人服务，例如：注册检验及现场核查、提交年度报告、发补意见的解决方案、临床试验登记、DSUR提交等等。

example

我司
1. 已成功代理登记并公示了一个进口原料药：盐酸罗沙替丁醋酸酯，登记号：Y20190000871，目前等待制剂关联；
2. 成功申报了培比洛芬缓释片IND申请，并获得《临床试验通知书》，目前在准备进行临床试验，计划在3年内提出上市申请许可。

进口药品注册成果展示

技术转让
助力国内药企

扬帆出海

我们致力于将拥有独特技术专利的中国药厂与匹配的海外公司精准对接。经由许可出让的方式，专利受让方将代为展开生产和销售，从而在行业中建立更加深入的合作。

这一战略不仅促进了技术资产的流动，还推动了中国创新者与国际制药企业之间的合作。依托我们在技术转让领域的专业优势和广泛网络，我们旨在推动行业创新，为各方创造互利共赢的机会。

助力海外药企

广济天下

我们专注于引进海外制药公司的先进剂型，力求填补中国临床需求的缺口。借由战略性的许可策略与布局，我们助力国际合作伙伴拓展版图，深化市场渗透，并将创新疗法惠及中国患者，达成共赢。

我们的核心领域包括：

  • 特殊制剂
    • 复方制剂
    • 改良剂型
  • 新药开发
GMP咨询与审计
面向国内制造商

cGMP咨询

我们在协助中国制造商顺利通过FDA、PMDA、EDQM、TGA等官方检查方面拥有卓越的成绩记录。凭借对GMP的深入理解和与制造商的紧密合作，我们致力于帮助药厂顺利通过各类供应商审计和官方检查。

我们提供全方位的cGMP咨询支持，服务范围涵盖但不限于以下方面：

  • 差距分析
  • 改进策略
  • 模拟审计
  • 官方检查现场支持（可提供英、日翻译）
  • 整改答复
面向海外客户

第三方审计

我们提供专业的现场审计服务，可代表海外客户进行供应商的资质审核和例行审计，并具备以下优势：

  • 对中国医药与化工行业的深刻洞察
  • 全球化视野下的cGMP专业知识
  • 丰富深厚的审计经验
  • 基于风险评估的审计方案
  • 全面报告与紧密跟进

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