Quality & Regulatory

Each part of our approach is built on solid principles, applied with rigour and transparency.

Analytical expertise under strict regulatory scope

We operate in full compliance with GxP guidelines to ensure the quality, safety and efficacy of your products.

• Good Manufacturing Practice (GMP): applied when supporting quality control, final product release testing and stability studies for drug substances and drug products. GMP ensures that medicines are consistently produced and controlled according to quality standards.
• Good Laboratory Practice (GLP): essential for non-clinical safety testing, GLP ensures data reliability, traceability and integrity during preclinical studies.
• Good Clinical Practice (GCP)/Good Clinical Laboratory Practice (GCLP): these standards govern bioanalytical support for clinical trials, guaranteeing the integrity of data generated.

Global reach and regulatory excellence

All our activities are governed by a comprehensive Quality System, documented within our Site Master File and executed via rigorous Standard Operating Procedures (SOPs). This system is designed for acceptance by major global regulatory agencies, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Our expert team conducts internal audits to confirm compliance with both internal SOPs and external regulations. We are fully accustomed to undergoing and successfully navigating client audits and regulatory inspections.

Continuous improvement and client focus

Every process is controlled, monitored and continuously improved to enhance efficiency and reliability. Your standards become our benchmark. We strive not only to meet your expectations but to exceed them, ensuring that every product we support is safe, compliant and ready for market.