We offer comprehensive project-managed IND services, covering the entire application process. Our integrated one-stop solutions ensure efficient project execution through robust management and competitive pricing, accelerating clients' IND approval timelines.
Clinical Registration Services
- Drug registration support for domestic/international clients under NMPA (National Medical Products Administration) framework
- Application and guidance for CDE (Center for Drug Evaluation) communication meetings
- Full documentation services for domestic IND (Investigational New Drug)/NDA (New Drug Application) submissions, including writing, review, preparation, and filing
- Regulatory strategy consultation and strategic planning support
- End-to-end submission lifecycle management and tracking
- Project management services (exclusive to clients with Mingjian-conducted preclinical studies)
Pre-submission phase: Organize internal technical review meetings for detailed program analysis. Post-submission phase: Senior regulatory affairs specialists maintain continuous communication with authorities, monitor review progress in real time, and drive the application to successful completion.
Competitive Advantages
- Proficiency in NMPA review frameworks and regulatory compliance, with expertise in resolving technical-regulatory challenges through strategic communication.
- Access to NMPA review experts enables targeted technical, regulatory, and strategic recommendations.
- Dedicated IND/NDA teams deliver integrated services spanning R&D, project management, and regulatory submissions.
- Real-time monitoring of regulatory updates ensures accurate and timely submissions.
Our clinical registration services provide customized strategies to mitigate risks, ensure compliant submissions, and expedite approval processes through proactive regulatory engagement.
