Swiss Class III Medical Device OEM Manufacturing Partnership

PA Company is a Swiss enterprise specializing in the research and development of innovative pharmaceutical and medical device products. Its Class III sterile ultrafine dry-powder medical device is being prepared for registration and commercialization in China. The company requires an OEM manufacturing partner with high-standard quality management capabilities and regulatory experience to support clinical registration and subsequent commercial production.

Leveraging its established network of medical device OEM manufacturers, industry expertise, and regulatory implementation experience, Reignite Med Tech Pharma successfully facilitated negotiations with PA Company. The parties have formally signed a Letter of Intent (LOI) to jointly advance the product’s regulatory registration and commercial manufacturing in China.

Project Scope

Clinical sample production: Approximately 3,000 units of the sterile ultrafine dry-powder product.

Collaboration model: The original developer will complete the core formulation process in Europe. Reignite Med Tech Pharma will identify, coordinate, and manage qualified manufacturing partners in China responsible for aseptic filling, capping, labeling, sterilization, and secondary packaging.