Capabilities
Quality System
Built-in Quality. Proven Compliance. Trusted Delivery.
At ReiThera, quality is not a function, it is embedded across every stage of development and manufacturing. Our integrated Quality System ensures that every product we support meets the highest international standards, enabling reliable delivery from early clinical phases through advanced development.
Our Quality framework is fully compliant with EMA and FDA cGMP requirements, and is continuously strengthened through regulatory inspections, client audits, and operational excellence.
Regulatory Track Record You Can Rely On
ReiThera operates under a strong and continuously validated regulatory framework:
GMP authorization granted by AIFA (Italian Medicines Agency) for the manufacturing of viral vector used as Genetic Vaccines, Gene Therapy and Advanced Therapy
Ongoing authorization for production and release of:
- Master and Working Cell Banks
- Master and Working Virus Seed
- Drug Substance and
- Drug Product
- Placebo and Solvent
Clinical materials currently released and used in trials across EU, UK, US, and Africa
Several successful client and expert audits since initial authorization
With 2 Qualified Persons (QPs) in-house, we ensure efficient batch certification and direct regulatory accountability.
Integrated Quality Oversight
Our Quality organization is designed for proximity to operations and rapid decision-making, ensuring seamless collaboration between Quality, Manufacturing, and Engineering.
Quality Assurance
Led by an experienced QA Director and supported by a dedicated team, our QA unit ensures full lifecycle oversight through:
- GMP documentation and data integrity management
- Change control systems
- Deviation handling and CAPA implementation
- Supplier qualification and internal audits
- Training programs and continuous compliance readiness
- Support for qualification and validation activities
Comprehensive Quality Control Capabilities
Our Quality Control laboratories provide a wide range of state-of-the-art analytical testing to support product characterization, release, and stability. Our QC organization includes dedicated experts and specialized laboratories, supported by a network of qualified external partners.
This hybrid model allows us to:
- Expand analytical capabilities rapidly
- Support highly specialized assays
- Ensure flexibility for complex or novel products
Our teams manage:
Early stage Analytical setting
- Analytical Development, feasibility study
- Analytical Transfer
- Analytical Methods Qualification & Validation
Release tests for DS & DP including
- Physicochemical Testing
- Potency & Functional Assays
- Identity & Molecular Characterization
- Safety Testing
- Environmental & Process Monitoring
Stability Monitoring
We support full ICH-compliant stability programs, covering:
- Long term Drug Substance and Drug Product
- Accelerated studies & Freeze and Thaw characterization
- In Use stability & Pharmacy Manual
Why ReiThera Quality is Different
Unlike many CDMOs, ReiThera combines:
Hands-on regulatory experience with multiple successful inspections
In-house QP release, ensuring speed and accountability
Flexible development and QC platforms designed to accelerate programs while reducing time, cost and complexity.
Agile, integrated teams working directly with manufacturing
Proven support for global clinical programs
This results in a Quality system that is not only compliant but responsive, collaborative, and built around client success.