Services Overview

TruoX Laboratories provides analytical and validation solutions engineered for accuracy, transparency, and regulatory confidence.
Our services are structured to meet the needs of pharmaceutical, biotechnology, and life-science organizations that demand audit-ready data and compliant workflows.

Current Focus

TruoX is currently in its pre-MVP stage, developing its proprietary TruoX LIMS and Computerized System Validation (CSV) suite.
These internal platforms are being validated in alignment with GAMP 5 (2nd Edition) and 21 CFR Part 11 principles.

Our immediate goal is to demonstrate full regulatory readiness and digital data integrity prior to the commissioning of our GMP analytical laboratory.

This approach allows TruoX to enter GMP operations with pre-validated digital systems, reducing compliance risk, inspection exposure, and time-to-first-sample.

Planned Phase I Laboratory Services

1. Small-Molecule Chemistry

• Impurity profiling and system suitability testing
• Raw-material, excipient, API, and finished-product testing

Planned Initial Software Products

1. TruoX LIMS

• Non-GMP or GMP-grade LIMS, depending on the partner's needs
• Software setup support, including configuration and validation documentation (URS, risk assessments, traceability matrices)

Future Capabilities

As TruoX progresses toward Phase I – GMP Quality Control Laboratory, the service portfolio will expand to include:

• Microbiology QC
• Stability Studies
• Computerized System Validation
• Biopharmaceutical Testing
• Automation & Data Analytics
• Contract Manufacturing Support

All service expansions will remain fully traceable within the TruoX LIMS and governed under the corporate Quality Management System (QMS).