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Copyright:2018-2025 All rights reserved Nanjing Gritpharma Co .,Ltd 苏ICP备15048906号 Power:www.300.cn 

Add:5th Floor, Building 9, Nanjing Life Science and Technology Innovation Town, No. 568 Longmian Avenue, Jiangning District, Nanjing, Jiangsu, China
Phone:025-83326929
Fax:025-83326929

 

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Registration service

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The company has a professional drug registration and reporting team. The team members have many years of experience in drug registration and first-line research and development. More than 50% of the team members have master's degree or above in pharmacy and related fields. Team members are familiar with innovative drug integrity. The R&D and declaration process has a deep understanding of the regulatory requirements of the drug testing center and the CTD format, and participates in the training of the drug testing center all the year round. The company has successfully applied for multiple new drugs and has several new drugs in progress. The company can now provide registered agency services including chemical, biological, medical and imported drugs, which can provide customers with new drug declarations and imported drug registration services that meet CFDA requirements with high efficiency and high quality.

The work we can carry out:

1. Medical data organization

- Data translation: Professional translation of FDA or EMA and other filing materials, and compiled into a book according to registration requirements;

- Literature search: search for pharmacy, pharmacology and toxicology and clinical literature at home and abroad;

2. Application review and submission

- Organize company teams or senior review experts to pre-assess the completeness and technicality of the application materials;

- registration data submission submission;

3. Declaration strategy formulation

- Find the fastest way to register drugs and avoid patent ownership issues;

- evaluate the feasibility;

4.CDE Q & A

- Consultation on difficult questions;

5. Registration tracking and communication

- Registration follow-up: CFDA will conduct preliminary examination after receiving the application materials, and issue the acceptance number after passing the preliminary examination, and arrange on-site assessment as needed;

- Technical review and monitoring: divided into evaluation start, professional review, comprehensive review, and review and transfer to the coordination department;

- Entry into the drug inspection and quality review (imported drugs);

- CFDA Administrative Approval: Follow up the CFDA administrative approval process to help the company ultimately obtain approval.

Related Links:

Drug Registration Management Measures

Drug Administration Measures

Drug Specification and Label Management Regulations