注册事务
Regulatory Affairs

序号

服务大类

核心服务内容

1

研发规划与注册咨询

R&D Planning and Regulatory Consulting

依据充分：所有研发规划均建立在大量翔实的文献调研和专家咨询的基础上。

Well-justified: All R&D planning is based on extensive literature research and expert consultation.

2

全程式规划：专家团队专业覆盖各领域和重要环节，提供从新药立项到新药上市的全程式规划。

Full-cycle planning: Our expert team provides comprehensive coverage across all therapeutic areas and key stages, offering full-cycle planning from drug discovery to market approval.

3

全程式研发指导：对项目进展全程跟踪，在关键阶段提供有价值的咨询和指导，使客户获得更大的附加价值。

Full-cycle R&D guidance: Continuous project tracking throughout the development process, with valuable consultation and guidance at critical stages, delivering greater added value to clients.

4

综述撰写与资料审核

Review Writing and Data Verification

立项目的与依据

Project Objectives and Justification

5

药学研究资料综述

Summary of Pharmaceutical Research Documentation

6

药理毒理学研究资料综述

Summary of Pharmacology and Toxicology Research Documentation

7

研究结果总结与评价

Summary and Evaluation of Study Results

8

国内外相关临床研究进展

Clinical Research Advances in China and Abroad

9

临床研究方案

Clinical Study Protocol

10

临床研究者手册

Investigator's Brochure

11

临床研究总结报告

Clinical Study Summary Report