QUALITY & COMPLIANCE

Ticinum Lab Pharma Research Center operates as a GMP-certified facility authorized by the Italian Medicines Agency (AIFA) to perform quality control testing on medicinal products and investigational medicinal products (IMPs), in full compliance with Directive 2001/83/EC. The center also holds certification for veterinary GMP quality control activities.

Recognized at an international level, Ticinum Lab is registered with the U.S. Food and Drug Administration (FDA) as an authorized testing facility for pharmaceutical product analysis (registration number 3005987780) and has successfully undergone FDA inspections since 2004.

This solid regulatory framework, combined with advanced analytical capabilities and state-of-the-art instrumentation, ensures that all activities are performed according to the highest GMP standards, delivering reliable, compliant, and audit-ready data to support clients throughout development, registration, and commercialization.

Ticinum Lab Pharma Research Center is certified by the Italian Health Authorities as a non-clinical research facility authorized to perform chemical and physical testing, pharmacokinetic/toxicokinetic and ADME studies, in accordance with Italian Legislative Decree DL120/92 and European Directives 1999/11/EC and 1999/12/EC.

In addition, the center is authorized by AIFA to operate as an analytical laboratory within Good Clinical Practice (GCP) studies, ensuring the generation of reliable, high-quality data in full compliance with applicable regulatory requirements.

Ticinum Lab Pharma Research Center is authorized by the Italian Health Authorities to handle and manage controlled drugs in full compliance with applicable national and international regulations. We operate under strictly controlled procedures covering procurement, storage, use, and traceability, ensuring the highest standards of security, documentation, and accountability.

This regulatory compliance enables us to support a wide range of analytical and research activities involving controlled substances, providing our clients with reliable, compliant, and fully traceable data throughout the entire project lifecycle.