Quality & Compliance

Quality at Plasmex Labs

Quality is at the core of Plasmex Labs.

• Strict donor screening protocols

• Ethical and regulatory compliance

• Controlled collection and handling processes

• Complete traceability and documentation

• Batch consistency for manufacturing applications

Our processes are designed to support the needs of diagnostic manufacturers, research institutions, and biotech companies..

Quality is the foundation of everything we do at PlasmexLabs. From donor selection to final product delivery, every stage of our operations is guided by strict quality controls, ethical standards, and industry best practices. We understand that precision and reliability are critical in diagnostics and research, and we are committed to delivering biological materials that consistently meet the highest standards.

Strict Donor Screening Protocols
We implement comprehensive donor qualification procedures, including medical history evaluation and health assessments, to ensure the safety, suitability, and integrity of every collected sample.

Ethical and Regulatory Compliance
Our operations are conducted in accordance with applicable regulatory guidelines and ethical frameworks. We prioritize donor safety, informed consent, and responsible handling of human biological materials.

Controlled Collection and Handling Processes
All collection and processing activities are performed under carefully monitored conditions to preserve sample integrity, minimize variability, and maintain quality throughout the supply chain.

Complete Traceability and Documentation
We maintain thorough documentation and tracking systems to ensure full traceability from donor to final product. This enables transparency, accountability, and confidence in every batch supplied.

Batch Consistency for Manufacturing Applications
We focus on delivering uniform, reliable batches suitable for manufacturing controls, calibrators, assay development, and validation processes, ensuring reproducibility and accuracy for our partners.

Our structured and quality-driven processes are specifically designed to support the evolving needs of in vitro diagnostic manufacturers, biotechnology companies, clinical research organizations, and academic institutions. By combining precision, compliance, and operational excellence, PlasmexLabs serves as a dependable partner in advancing diagnostic and life science innovation.