Global biotech advancing a rare-disease iRNA therapy needed a China regulatory and access pathway aligned with aggressive NDA NRDL timelines.
A growing auto component manufacturer, partnered with Industro to modernize its legacy production setup and transition into a smart factory environment. Facing challenges with outdated systems, manual data entry, and unplanned downtime, the company needed a digital overhaul that wouldn’t disrupt daily operations. With increasing customer demands, rising operational costs, and downtime impacting delivery timelines, they recognized the urgent need for a smart factory transformation.
Over a 3-month engagement, Industro implemented IIoT sensors, integrated MES with existing ERP, and deployed AI-driven dashboards to deliver real-time visibility, predictive maintenance, and measurable improvements in efficiency.
With modern dashboards, integrated systems, and real-time performance monitoring, NovaDrive now operates with greater control, efficiency, and transparency.
• Rapidly evolving RNA and rare‑disease guidance
• Ensuring global data suitability for China & CDE expectations
• Align pathway with annual NRDL cycle.
China regulatory pathway design (priority review, clinical/CMC alignment, NRDL link)
Pre‑NDA engagement with CDE to align expectations and data package.
NDA execution: CTD dossier & China‑specific modules
Policy & exclusivity advisory for incentives & exclusivity routes.
Commercial integration with NRDL/pricing planning.
integrated regulatory and market access strategy enabled successful approval and NRDL listing.
Their integrated regulatory and market access strategy positioned us for successful approval and NRDL listing.
