Quality Compliance
Capable of manufacturing solid, liquid, and semi-solid dosage forms, BioDuro – Sundia’s Drug Product Manufacturing team provides a comprehensive service for clinical trial material preparation in support of Phase 0 to Phase II studies. Our contract pharmaceutical manufacturing services are cGMP compliant and include established clinical trial material management SOPs with QA oversight.
Quality & Compliance
- Coupled with BioDuro-Sundia’s partnership with ABF pharmaceuticals, our cGMP validated and monitored warehouse allows us to provide seamless supply chain management resources to our clients. Our San Diego based cGMP warehouse will give you quality pharmaceutical warehousing, while our partners at ABF provide seamless clinical distribution services. Our close partnership with ABF enables us to provide our clients with a simple solution to complex clinical trial supply problems.
Services
- Customized training modules for new hires and continuous training for current employees
- Internal Audits are performed and resolved in a timely manner
- Robust Deviation Management system with root cause analysis and an effective corrective action preventive action (CAPA) system
- Supplier management program is in place
- Timely response to client and regulatory observations
- Metrics are gathered and discussed for continuous improvement
- Technical review of data undergoes rigorous scrutiny