GMP Manufacturing Services

Contract manufacturing operations for diagnostic products and components under Good Manufacturing Practice standards. Includes process validation, quality assurance, and full regulatory compliance documentation.

Full-scale cGMP and ISO 13485 compliant manufacturing services for in vitro diagnostic products. Supports formulation, fill, finish, and distribution from concept to commercial scale.

Specialized manufacturing services for medical and pharmaceutical products in cleanroom environments meeting ISO 13485 and GMP standards. Includes production, assembly, sterilization, and quality control.

On-site contract manufacturing for biological reagents and antibody products. Includes process innovation expertise and customized production capacity.

Contract manufacturing and assembly services for medical devices and healthcare products. Facilities are certified by national regulatory authorities and operate under GMP standards.

Full manufacturing services for diagnostic devices including production control, validation, and quality assurance under ISO13485 standards.

Large-scale, customized antibody production services performed under GMP standards. SDIX manufactures antibodies to specification for diagnostic and pharmaceutical applications.

Contract manufacturing services for customized microbial control materials and diagnostic reference products.

Contract manufacturing services operated under ISO 13485 quality management systems for medical device production and compliance.

Sterilization services for medical disposables and single-use devices, ensuring compliance with ISO13485 and GMP standards.

Contract manufacturing services for medical devices including design, production, and quality assurance. Operates in certified facilities meeting medical device manufacturing standards and regulatory requirements.

In vitro diagnostic contract manufacturing services for diagnostic reagents and assay components under ISO13485 quality standards.