Calbiotech - Contract Development and Manufacturing for Life Science

Accelerating Diagnostics Through Custom Solutions

From assay development to scalable manufacturing, Calbiotech supports your IVD innovation every step of the way.

FDA-Registered U.S. Manufacturer

California-based, FDA-registered, and ISO 13485-certified CDMO — trusted for U.S.-origin quality and regulatory compliance.

Assay Development Expertise

25+ years of experience in immunoassay, molecular, and multiplex formats — from concept to commercialization.

U.S. Market Access

We help global diagnostics companies with U.S. registrations, manufacturing, and commercialization.

Global Access to U.S. Innovation

Manufacture locally with Calbiotech support — lower costs, streamline logistics, and improve access to tenders.

End-to-end support — from development to delivery.

Assay Design & Optimization
Accelerate development with expert assay design, biomarker validation, and format flexibility.
Proven Manufacturing Expertise
Over 25 years of IVD experience ensures robust, scalable, and cost-effective assay production.
Regulatory & Quality Support
ISO 13485-certified systems with in-house QC and documentation support for global compliance.
Scale-Up & Fulfillment
From clinical pilot lots to full production, we handle kitting, packaging, and global logistics.