CROlife is pleased to announce the achievement of the UNI EN ISO 9001:2015 certification, a significant milestone that confirms the company’s commitment to quality, compliance, and continuous improvement.

The certification applies to CROlife’s Quality Management System (QMS) and covers the following scope:

IAF: 34
Provision of Contract Research Organization (CRO) services for the clinical development of pharmaceutical products and medical devices.

The UNI EN ISO 9001:2015 standard is internationally recognized as a benchmark for quality management. It certifies that an organization has implemented effective processes to ensure consistency, efficiency, risk management, and customer satisfaction, while promoting a culture of ongoing improvement.

For CROlife, this certification represents formal recognition of a structured and robust organizational model designed to support clinical research activities in compliance with regulatory requirements and industry best practices. It reflects the company’s ability to deliver CRO services through standardized, traceable, and continuously monitored processes.

Achieving ISO 9001:2015 certification further strengthens CROlife’s positioning as a reliable partner for sponsors, pharmaceutical companies, and medical device manufacturers, ensuring that clinical development activities are conducted according to the highest quality, ethical, and operational standards.

Quality is a strategic pillar of CROlife’s approach to clinical research. The implementation and maintenance of a certified Quality Management System enable the company to enhance operational performance, mitigate risks, and ensure transparency and consistency across all services provided.

CROlife will continue to invest in quality, innovation, and regulatory compliance to support the successful development of pharmaceutical products and medical devices, contributing to the advancement of clinical research and patient care.