At LineaRx, Quality is the foundation of everything we do. As an ISO 9001:2015 accredited company we are committed to and obligated to uphold the highest standards of compliance in maintaining our current Good Manufacturing Practices (cGMP) status. Our compulsion for excellence starts from Process development and continues through the Final Production and Analytical Testing of our enzymatic DNA-based solutions. Our commitment to Quality and Compliance also ensures that product innovation and services are delivered to meet or exceed regulatory, industry, and customer expectation.
Quality Certifications & Accreditations
LineaRx Quality Management System operates under ISO 9001:2015 certification by NSF.
Our Quality Commitment Includes:
- Compliance with Industry Standards – In collaboration with numerous customers and industry experts, our company’s internal regulatory compliance system harmonizes ISO 9001, ISO 13485, FDA 21 CFR Parts 210, 211, and 820 into one cohesive Quality System. By doing so, we adhere to FDA’s current Good Manufacturing Practices (cGMP) and ISO regulatory guidelines for medical devices which have become the de facto reference for the biopharmaceutical industry to ensure consistent product quality, safety, purity, and efficacy.
- Rigorous Quality Control and Internal Auditing – LineaRx product deliverables are rigorously tested and reviewed by our Quality Control and Quality Assurance professionals to verify consistency, accuracy, reliability, and adherence to established specifications and standard operating protocols. We monitor, measure and perform internal audits on key operating parameters to ensure a quality culture.
- Continuous Improvement – We foster a culture of quality-driven innovation, continually refining our processes to meet evolving scientific and regulatory demands. Through customer reviews, audits, and CAPA feedback mechanisms, the company drives continuous improvement in its processes, products, and services.
- Customer Focus – We are committed to meeting or exceeding customer expectations by providing high-quality, customized DNA solutions for advanced applications.
- Risk-Management –The company applies risk-based approaches throughout all aspects of the product lifecycle, from product development to product production to post-market activities.
At LineaRx, quality is in our DNA — driving precision, innovation, and excellence.
Central to our approach is our certified GMP-compliant facility. Integrating our rapid enzymatic, PCR-based DNA production technologies within a cGMP framework, we ensure that every step of production is thoroughly documented and QC analyzed prior to final disposition with Quality release documentation. Whether destined for research or clinical application we assure that your final product will meet your established specifications. This facility not only reinforces the reliability of our platforms but also supports and facilitates your seamless transition from discovery to drug product, paving the way for clinical and commercial success.