In the era of biologics, global regulatory capability is your core competitive advantage.
With explosive growth in GLP‑1, insulin, growth hormone, and other biologics, safety and compliance standards for drug delivery systems are rising fast. NEST delivers a full‑chain solution built on "High Standards, Strong Compliance, Global Reach."
Core Capabilities
1️⃣ Integrated R&D & Manufacturing: In‑house core structure development, mold design, and automated production — with full customization (appearance, dosage, scale markings).
2️⃣ Full Product Coverage: Disposable/reusable pen injectors, prefilled autoinjectors, ready‑to‑use cartridges, COP/COC syringes, nasal spray devices — compatible with GLP‑1, insulin, and more.
3️⃣ Consistent Quality: Automated assembly + standardized processes meet the highest standards for drug-device integration.
4️⃣ Patent Safety: FTO analyses completed for China, US, and Europe — systematically mitigating international patent risks.
5️⃣ Supporting Equipment: Filling & stoppering systems, standalone stopper machines — full support from process development to production.
Global Certifications as a Moat
✅ FDA 510(k): K240961 | K240774
✅ EU MDR Certified
✅ MDSAP (US, Canada, Australia, Japan, Brazil)
✅ 6 U.S. DMF Filings (40744 / 42439 / 40629 / 40922 / 40745 / 38260)
✅ CDE Linked Reviews (including I‑to‑A status) + China Class II Medical Device Registration
Global Footprint
? Registration and certification network covering China, the US, Canada, the EU, Southeast Asia, and South America — delivering stable, efficient, and sustainable supply chain support to pharma partners worldwide.
Moving forward, NEST will continue to deepen capabilities in pen injectors and autoinjection systems, advancing quality systems and international registrations to provide safer, more efficient, and more reliable drug delivery solutions for the global biopharmaceutical industry. ? ? ?
