End-to-End CDMO Services

Accelerating Industrial Production and Market Launch of Drug Device Combination Products.

From process design and scale up stability to market entry risk assessment, we support clients in translating high barrier technologies into globally marketable products.

Industrial Nozzle
 

Industrial Nozzle
Filtration Components →

Industrial Nozzle & Filtration Components

  • Ink Cartridge Nozzles
    Supporting polyimide (PI), stainless steel, and other materials.
  • Large Industrial Inkjet Head Elements.
  • Microfluidic Channel Design
    Applicable to filter plates and precision fluid control systems.
Drug and Device
 

Drug and Device Combination→

Drug and Device Combination

  • Smart Nebulization Systems
    Supporting breath actuated, personalized respiratory therapy.
  • Compatible with a Wide Range of Drug formulations
    Including small molecule drugs (solutions and suspensions) and large molecule drugs (proteins, liposomal formulations, etc.), meeting module requirements for high-viscosity fluids (>2 cP) and low shear protection.
    Rapid Feasibility Study:
    Step 1
    NDA signing and sample solution
    Step 2
    Particle size analyze
    Step 3
    Preliminary report delivered within 10 days
  • Mesh Nebulizer
  • Microfluidic Design
    Applied to biomedical organ chip applications.
High-Efficiency Manufacturing
 

Scalable, High-Efficiency
Manufacturing Processes →

High-Efficiency Manufacturing

  • QbD (Quality by Design) Process Strategy
    Customizable critical process parameters.
  • Internationally Certified Manufacturing
    Compliant with ISO 9001, ISO 13485, ISO 22716, and other global standards.
  • Smart Manufacturing Implementation
    Automated inspection, high-precision measurement, real time monitoring, and early warning systems.
Commercialization
 

Commercialization
and Product Launch →

Consulting Services

  • Global Regulatory Experience
    20 countries including US (FDA), EU (MDR), Taiwan (TFDA), China (NMPA), Brazil (ANVISA).
  • Global IP Portfolio
    Across 31 countries, reducing post market intellectual property risks.
  • Analytic and Calibration Lab
    Third party certified in vitro performance testing for inhalation products.
  • Market Strategy
    Assistance in commercialization planning and market entry strategies.

 

Service Process

Industrial Nozzle Plate

Application requirement confirmation
Design drawings
Process feasibility assessment
Photomask development
Pilot production & validation
Mass production
Packaging & labeling

Drug and Device Combination

Drug viscosity assessment
Device design
Mold development
Pilot-scale production
Biocompatibility testing
Third-party laboratory validation
Medical device regulatory registration
Component mass production
Assembly
Packaging & labeling