Services
Quality
Quality assurance support for medical devices, drugs, biologics, diagnostics, and tissue products.
Chemistry Manufacturing and Control
Pharmaceutical and Biologics specific manufacturing processes, product characterization and testing.
Regulatory
Biomedical products regulatory support to ensure compliance with laws and regulations.
Global Coverage
Consulting support for Global regions and countries including: United States, Europe, Australia, South America, Canada, China, and Japan.
cGxP
Current good manufacturing practices for: Medical Devices, Pharmaceuticals, In Vitro diagnostics, Biologics, and HCT/P.
Regulatory Documentation and Submissions
FDA submission documents including; 510k, IND (Investigational New Drug) , TMF (Trial Master File),
European Union Technical Documentation / Clinical Evaluation Report (CER)
