Excellence in Every Process, Safety in Every Step
Quality & Compliance
Our Commitment to Quality
At Bioscience Institute, quality is not merely a standard, it is the foundation of our mission. Every procedure, from sample collection to long-term cryopreservation, adheres to the strictest international protocols and regulatory requirements. Our comprehensive quality management system ensures that your biological samples are processed, tested, and stored with the utmost care and precision.
We operate under rigorous Good Manufacturing Practice (GMP) guidelines and maintain multiple international certifications that validate our commitment to excellence. Our quality assurance team continuously monitors all processes and implements improvements based on the latest scientific advancements and regulatory updates.
Certifications & Accreditations
GMP Certification - Good Manufacturing Practice
Our laboratories operate under strict GMP guidelines, ensuring that all cell processing and manufacturing activities meet pharmaceutical-grade quality standards. This certification validates our controlled environments, documented procedures, and trained personnel in delivering consistent, high-quality biological products.
ISO 9001:2015 - Quality Management System
Bioscience Institute holds ISO 9001:2015 certification, demonstrating our commitment to implementing and maintaining an effective quality management system. This international standard ensures continuous improvement in all our processes and customer satisfaction.
AIFA Authorization - Italian Medicines Agency
We are authorized by AIFA (Agenzia Italiana del Farmaco) for the processing and storage of biological materials. This authorization confirms our compliance with Italian and European regulatory requirements for cell-based products and services.
Ministry of Health Authorization
Our facilities are authorized by the Ministry of Health for tissue banking activities, ensuring full compliance with national regulations governing the collection, processing, and storage of human tissues and cells.
Our Quality Pillars
Safety First
Comprehensive testing protocols for infectious diseases, sterility, and cell viability ensure the safety of every stored sample.
Traceability
Complete chain of custody documentation from collection to storage, with unique identification for every sample.
Continuous Improvement
Regular audits, staff training, and process optimization to maintain the highest standards of quality.
Request Documentation
Need detailed information about our certifications?
Contact our Quality Assurance team to receive copies of our certifications, compliance documentation, or to schedule a facility tour.
