Documented required utility conditions, and requirements for facilities and equipment as URB in accordance with the expected product production volume, manufacturing environmental standards, Vietnamese national regulations, Chinese medical device regulations, MDR, 21CFRPart820 (QSR), and the Pharmaceutical Affairs Law.

In the basic plan, we organized the flow lines of people and goods, environmental standards, and changing systems, and studied the floor plan and cross-sectional plans, including plans for existing renovations according to the manufacturing operations in each process,

We completed the basic design with a structural plan and material selection that matched the actual conditions of the construction site (Vietnam).

At the construction inquiry stage, we prepared specifications for quotation inquiries, design documents, and requirement specifications for validation with clear specifications. This made it possible to conduct quotations for multiple companies and to evaluate quotations fairly.

During the detailed design and construction phase, our CM and four Vietnamese engineers were stationed at the site to supervise the construction work, including checking the construction progress, checking construction quality, confirming changes, and assessing additional construction costs, thereby contributing to ensuring good construction quality.

Smooth start-up of production facilities was made possible through close coordination between customer-arranged production facilities and the building.

Based on LQA (Lean Qualification Approach), we supported the creation of validation documents for architecture, air conditioning, and logistics equipment.