Registration service
The company has a professional drug registration and application team. The team members all have many years of drug registration and application experience and front-line research and development experience. More than 50% of the team members have a master's degree or above in pharmacy and related majors. The team members are all familiar with the integrity of innovative drugs. R&D and application process, have in-depth understanding of the regulatory requirements and CTD format of the Center for Drug Evaluation, and participate in Center for Drug Evaluation training all year round. The company has successfully applied for multiple new drugs and has several new drugs under development. The company can now provide registration agency services including chemical drugs, biological drugs, medical devices, and imported drugs, and can provide customers with new drug declaration and imported drug registration services that meet NMPA requirements with high efficiency and high quality.
Now the company can accept the following service entrustment:
1. Compilation of medical data
- Data translation: Professional translation of application materials from FDA or EMA, etc., and compiled into volumes in accordance with registration requirements;
- Literature search: Search domestic and foreign pharmaceutical, pharmacology and toxicology and clinical literature;
2. Review and submission of application materials
- Organize a company team or senior review experts to conduct a pre-review on the completeness and technicality of the application materials;
- Compile and submit registration information;
3. Declaration strategy formulation
- Find the fastest way to register drugs and avoid patent ownership issues;
- Evaluate feasibility;
4.CDE Q&A
- Consultation on difficult issues;
5. Full registration tracking and communication
- Registration follow-up: NMPA will conduct a preliminary review after receiving the application materials. After passing the preliminary review, an acceptance number will be issued and on-site assessment will be arranged as needed;
- Technical review monitoring: divided into review initiation, professional review, comprehensive review, and transfer to the coordinating department after review;
- Inspection and quality review of imported drugs (imported drugs);
- NMPA administrative approval: Follow up the NMPA administrative approval process to help companies finally obtain approval.
Address: Nanjing Life Science and Technology Innovation Park, 568 Longmian Avenue, Jiangning District, Nanjing City, Jiangsu Province
