Regulatory Ready Manufacturing Strukmyer offers FDA device and drug registration, ISO 13485 certification, Class 8 cleanrooms, and in-house labs with end-to-end development support, enabling faster time-to-market with a single manufacturing partner.

Sterile Solutions Expansion Recent FDA clearance to produce sterile saline and sterile water for wound dressings and dermal lesions creates a new product category and cross-sell opportunities with wound care brands and healthcare providers.

Distributor Partnerships A track record serving major distributors and brands such as Cardinal Health, Medline, McKesson, and Church & Dwight demonstrates credibility and scalability to engage similar large customers.

Co-development Opportunities Strukmyer emphasizes collaborative product ideation across medical devices, cosmetics, and OTC drugs, making it a compelling partner for early-stage concept development and rapid prototyping.

Scalable CMO Advantage With a 100,000 square foot facility, Class 8 cleanrooms, USP 0.2 micron water filtration, ISO 13485, and end-to-end capabilities from R&D to sterilization and packaging, Strukmyer can serve as a single source for mid-sized brands seeking speed, quality, and regulatory compliance.