Quality Assurance & Compliance
As a licenced contract research organization, DiTEBA provides high quality analytical and bioanalytical testing services to the pharmaceutical, biotechnology, medical device and natural health product industries.
Our services are performed in accordance with the requirements of:
- The U.S. Food and Drug Administration (FDA)
- Health Canada
- European Medicines Agency (EPA)
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- International Conference on Harmonization (ICH)
At DiTEBA, we have a level of quality assurance and regulatory compliance that is unmatched in the life sciences industry. We have created a fully operational and integrated quality assurance environment that combines traditional quality assurance settings with the most advanced e-lab technology infrastructure in compliance with the most stringent regulations of GxP and U.S. FDA 21 CFR Part 11 regulation (Electronic Records and Electronic Signatures).
Licences and registrations
FDA Inspected 2014 and 2015
Licenced by Health Canada
- GMP Drug Establishment Licence (DEL)
- To handle controlled drugs, substances and precursors
- To handle biological-biotherapeutics (Schedule D)
- Registered to handle human pathogens
Laboratory instrument data
Data generated by all chromatographic systems is captured and processed by the Waters Empower® software system. Empower addresses our sponsors’ concerns for data security, compliance and validation and allows us to maximize the productivity of our laboratory instrumentation.
Data capturing, processing and archiving
The core building block of our data infrastructure is the web-based Waters NuGenesis® Scientific Data Management System (SDMS) platform, providing us with the foundation for data preservation and integrating the flow of information throughout the organization. NuGenesis® SDMS provides our sponsors with a fully electronic audit trail and an enhanced data security environment.