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Registration of APIs, excipients and packaging materials, registration of pharmaceutical excipients and pharmaceutical packaging materials,
Registration of Domestic/Imported APIs

Chemical synthesis APIs: 100+,Fermentation APIs: 20+,Extraction APIs: 10+

Registration of Domestic/Imported APIs

Chemical synthesis APIs: 100+,Fermentation APIs: 20+,Extraction APIs: 10+
Medicinal excipients and registration

Pharmaceutical excipients,Ordinary excipients, high-risk excipients
Medicinal excipients and registration

Pharmaceutical excipients,Ordinary excipients, high-risk excipients
Registration of Special Products

DMFs filing of media，DMFs filing of enzymes，Application for nuclide products
Registration of Special Products

DMFs filing of media，DMFs filing of enzymes，Application for nuclide products
Services of DMFs

Drug Master Files (DMFs) are submissions to Food and Drug Administration (FDA)
Services of DMFs

Drug Master Files (DMFs) are submissions to Food and Drug Administration (FDA)
Services of CEP

the certificate of suitability to monograph of European pharmacopeia (COS/CEP)
Services of CEP

the certificate of suitability to monograph of European pharmacopeia (COS/CEP)

Provide

Professional

advisory service
International GMP Certification

New (rebuilt) plant (workshop)Pre-approval GMP inspection
International GMP Certification

New (rebuilt) plant (workshop)Pre-approval GMP inspection
Registration of Domestic/Imported APIs

Chemical synthesis APIs: 100+,Fermentation APIs: 20+,Extraction APIs: 10+

Registration of Domestic/Imported APIs

Chemical synthesis APIs: 100+,Fermentation APIs: 20+,Extraction APIs: 10+

Medicinal excipients and registration

Pharmaceutical excipients,Ordinary excipients, high-risk excipients
Medicinal excipients and registration

Pharmaceutical excipients,Ordinary excipients, high-risk excipients
Registration of Special Products

DMFs filing of media，DMFs filing of enzymes，Application for nuclide products
Registration of Special Products

DMFs filing of media，DMFs filing of enzymes，Application for nuclide products
Services of DMFs

Drug Master Files (DMFs) are submissions to Food and Drug Administration (FDA)
Services of DMFs

Drug Master Files (DMFs) are submissions to Food and Drug Administration (FDA)
Services of CEP

the certificate of suitability to monograph of European pharmacopeia (COS/CEP)
Services of CEP

the certificate of suitability to monograph of European pharmacopeia (COS/CEP)
International GMP Certification

New (rebuilt) plant (workshop)Pre-approval GMP inspection
International GMP Certification

New (rebuilt) plant (workshop)Pre-approval GMP inspection
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0

CEP certification

0

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Imported APIs

0

+

Pharmaceutical excipients

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0

Packaging material registration

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0

DMF registration

About Xizimed
Xizimed is a CRO specializing in registration of APIs, excipients and packaging materials and compliance consulting services, including Shenyang Xizi Biomedical Technology Service Co., Ltd. and its subsidiary Beijing Xizimed Consulting Inc. We are committed to providing domestic and foreign customers with the most professional and precise registration and compliance consulting services for APIs, pharmaceutical excipients and packaging materials, to build the most time-saving and labor-saving approaches of listing.
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Shenyang Xizi Biomedical Technology Service Co., Ltd
Xizimed is a CRO specializing in registration of APIs, excipients and packaging materials and compliance consulting services, including Shenyang Xizi Biomedical Technology Service Co., Ltd. and its subsidiary Beijing Xizimed Consulting Inc. We are committed to providing domestic and foreign customers with the most professional and precise registration and compliance consulting services for APIs, pharmaceutical excipients and packaging materials, to build the most time-saving and labor-saving approaches of listing.
More

Company advantages

Your Trustworthy Professional Regulatory Consultants for APIs, Excipients, and Packaging Materials!
Outstanding & Professional Team
Outstanding & Professional Team
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Perfect quality assurance
Provide professional, efficient and exact one-stop regulatory service
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Sound Industry Reputation
Formed regulatory partnerships with more than 100 corporations domestic and overseas
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Reliable Data Protection System
Self-encrypting system ensures that any technical documents will not be disclosed
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Training

Professional CRO for original and auxiliary package registration and compliance consulting services
Domestic and international registration management of pharmaceutical excipients and pharmaceutical packaging materials... Domestic and international registration management of pharmaceutical excipients and pharmaceutical packaging materials... Import registration and change maintenance of chemical APIs... Import registration and change maintenance of chemical APIs (upper part) Requirements for the bundling review and technical evaluation of APIs, excipients and packaging materials.
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Focus

Professional & Efficient Industry Leader
IPEC China Excipients Conference 2025 Concluded Successfully
Huang Guo Conducted an Investigative Research on the Management of APIs in Zhejiang
XIZIMED Makes a Splash at the 93rd API China
Good news | Xizimed has passed ISO 9001 quality management system certification
Through nearly a year of hard work and pioneering practice of all employees, Xizimed successfully passed the CQC ISO 9001 quality management system certification, providing a good guarantee for the quality of projects for new and old customers at home and abroad.
Copy | Notice on the Requirements for Submissions in Electronic Format of Drug Registration
按照《 药监局关于实施药品注册申请电子申报的公告》（2022年第110号）要求，自2023年1月1日起，申请人提交的 药监局审评审批药品注册申请以及审评过程中补充资料等，调整为以电子形式提交申报资料，现就电子申报具体要求通知如下：
Copy | Announcement of NMPA on the Issuance of the Administration of Post-approval Changes to Drugs (Trial Implementation) (No. 8 in 2021)
为贯彻《药品管理法》有关规定，进一步加强药品上市后变更管理， 药监局组织制定了《药品上市后变更管理办法（试行）》，现予发布，自发布之日起施行，此前规定与本公告不一致的，以本公告为准。各省级药品监管部门应当落实辖区内药品上市后变更监管责任，细化工作要求，制定工作文件，明确工作时限，药品注册管理和生产监管应当加强配合，互为支撑，确保药品上市后变更监管工作平稳有序开展。
Copy |Announcement of NMPA on the Re-issuance of the Fee Standards for Drug Registration (No. 75 in 2020)
根据《药品注册管理办法》（ 市场监督管理总局令 第27号）、《关于重新发布中央管理的食品药品监督管理部门行政事业性收费项目的通知》（财税〔2015〕2号）和《关于印发〈药品、医疗器械产品注册收费标准管理办法〉的通知》（发改价格〔2015〕1006号）， 药品监督管理局制定了《药品注册收费标准》《药品注册收费实施细则》，现予公布，自2020年7月1日起施行。
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Contact
Tel: +86-24-31699170
Address：Room 1713, Building A, China Merchants Tower, 7-2 Yingpan North Street, Hunnan District, Shenyang, China
Address：608, Building A, Tongzhou Wanda Plaza, Tongzhou District, Beijing, China

Record No.: Liao ICP Record No. 2022008769-2
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