Collaborating with top biotech and pharma companies globally, we enhance our expertise to offer comprehensive services for client projects.
l Team: A team of 83 professional R&D personnel.
l Composition: Interdisciplinary team including biologists, chemists, medical experts, mechanical engineers, material scientists, electronics specialists, automation experts, and computer scientists.
l Development timeline: Over 32 months for the R&D of a multi-dose autoinjector.
●Strong relationships with clients
●In-house industrial design team and usability experts
●Quick to Market™ services
●We listen to market trends and use our local and global industry network to stay informed about developments in drug formulation and primary packaging. Integrating this insight with innovative processes and ongoing tech analysis, we continuously develop and refine our injection systems, with our clients actively involved in our innovation journey.
We custom-order and procure high-precision, high-performance injection molds from the most experienced companies at home and abroad. To ensure the performance and quality of each precision mold, we have a dedicated maintenance team that guarantees our molds' excellent repeatability, durability, and short molding cycles.
Our factory provides customized assembly solutions combined with robust manufacturing processes, capable of meeting diverse production requirements. Additionally, our well-trained and experienced workforce ensures efficient production processes and high product quality standards.
Equipped with semi-automatic and fully automatic testing and assembly machines, as well as integrated robotic systems, our automation equipment enhances production efficiency and consistency. We also offer comprehensive service and maintenance support to ensure the stable operation of our automated systems.
l Broke through international patents of pen injection product, possessing proprietary patent technology for auto-injection pens.
l Passed FTO (Freedom-to-Operate) infringement analysis.
l Has secured 110 patents and has 33 patents pending application
l ISO 13485 Certified
l Manufacturing License
l Class II Medical Device Registration Certificate in China
l Pharma Packaging Materials Filing and Recordation
l US DMF (Drug Master File) Filing
l CE Mark (Pending Certification)
●Device performance optimization
●Mechanical simulation
●Sub assembled components analysis
●Customized and tailored methods
●We design, procure, or develop bespoke automated assembly, testing, rotary table, vision, linear, robotic pick-and-place, packaging systems, pre-production equipment, and pharmaceutical assembly systems tailored to specific components and customer requirements. We assist clients in establishing release criteria and provide system testing solutions post-device combination to support quality control.
●Regulatory submission services for combination products in China and Europe
●Assisting clients with DHF documentation and stability testing data.
●Clinical and NDA submissions
●We provide comprehensive regulatory support according to supervisory requirements and client expectations, including manufacturing registration, equipment filing, and post-marketing activities.