IVD Regulatory Pathway Support Service

Expert consulting service for in vitro diagnostic product development including assay formulation and integration. Multidisciplinary team provides support in molecular biology, quality control, injection molding, and microfluidics. Accelerates time-to-market for diagnostic solutions.

Regulatory consultation and support services for in vitro diagnostic product registration and market listing. Assists manufacturers in navigating regulatory requirements for diagnostic devices.

Full-service in vitro diagnostic development for human, animal, and therapy-related applications from concept to market.

Contract research organization service specializing in in vitro diagnostic test validation. Services include ethics approvals, study design, sample provision, laboratory analysis, and regulatory compliance documentation for EU IVDR, TGA, and WHO standards.

Manufacturing and development service for CE IVD certified diagnostic kits including real-time PCR formulations, controls, and reagent components. Supports custom product development for diagnostics companies.

Expert regulatory support for medical device approval including MDR and FDA compliance guidance. Provides data-driven safety dossiers and toxicological risk assessments to accelerate time-to-market globally.

Comprehensive service supporting development of diagnostic devices from concept through manufacturing. Includes platform selection, process optimization, and scale-up support. Bridges gap between R&D and regulated production.

Clinical and analytical study support services for diagnostic validation and regulatory submissions.

A service that facilitates regulatory compliance and market entry for medical devices and in vitro diagnostics (IVDs) in Southeast Asia. This service assists manufacturers in navigating regulatory requirements and establishing their products in the Southeast Asian market.

Regulatory registration and testing service for active medical devices, passive medical devices, and in vitro diagnostic reagents. Supports compliance with medical device classification, clinical evaluation, and submission requirements for market authorization in regulated territories.

Original equipment manufacturing and original design manufacturing services for in vitro diagnostic products. Includes product incubation, formulation development, registration support, and commercialization assistance.

Specialized service supporting regulatory registration and compliance documentation for endoscope systems and components. Assists manufacturers in meeting medical device regulatory requirements for market approval.