Bioanalytical Quality Assurance and Regulatory Compliance

Quality is at the core of every project at SmartBio Analytics. Our bioalanytical quality assurance systems and GLP-compliant processes help ensure reliable, accurate and regulatory-ready analytical data.

We maintain a robust Quality Assurance (QA) system aligned with OECD GLP principles, as well as FDA and EMA requirements, to guarantee data integrity from sample reception to final reporting. 

GLP Certification

SmartBio Analytics is the first and, so far, the only GLP-certified bioanalytical laboratory in the Community of Madrid. You can view and download our official GLP certificate here! 

Quality Assurance for Reliable, Regulatory-Ready Bioanalysis

Our Quality Assurance Approach

Speed Without Compromise

Full Regulatory Compliance

Adherence to OECD GLP, FDA, EMA, and ICH guidelines

Regulatory Confidence

Traceability

Complete documentation and chain of custody for all samples and data

Collaborative Approach

Continuous Improvement

Regular audits, internal reviews, and staff training to maintain and enhance quality standards

State-of-the-Art Equipment

Data Integrity

Strict controls to ensure accuracy, reproducibility, and secure data management

Proven Scientific Expertise

Validated Systems

All analytical and IT systems validated according to GAMP and OECD 17

Our commitment to quality is not just about compliance — it’s about delivering results you can trust, every time