Our expertise
Qualification & Validation
| ATMP | Biotech | In VitroDiagnostics | MedicalDevices | SmallMolecules | DigitalHealth | |
|---|---|---|---|---|---|---|
| Process & Cleaning | ||||||
| Environmental Monitoring Services | ||||||
| IT Insfrastructure QualificationIT Insfrastructure Qualification | ||||||
| Computer System Validation | ||||||
| Data Integrity | ||||||
| Equipment Validation |
Quality Assurance
| ATMP | Biotech | In VitroDiagnostics | MedicalDevices | SmallMolecules | DigitalHealth | |
|---|---|---|---|---|---|---|
| Clinical QA | ||||||
| Performance Evaluation Studies | ||||||
| Device Compliance | ||||||
| QMS Consulting for IVD Companies | ||||||
| QP Services | ||||||
| Audit Services | ||||||
| Compliance Specialist |
Regulatory Affairs
| ATMP | Biotech | In VitroDiagnostics | MedicalDevices | SmallMolecules | DigitalHealth | |
|---|---|---|---|---|---|---|
| Pharmacovigilance & Drug Safety | ||||||
| Person Responsible for Regulatory Compliance (PRRC) | ||||||
| Legal Representative Clinical Trials | ||||||
| In Country Representative Services | ||||||
| Performance Evaluation Studies | ||||||
| Device Compliance | ||||||
| Regulatory Affairs for Medical Devices | ||||||
| Regulatory Affairs for Pharma and Biotech |
Clinical
| ATMP | Biotech | In VitroDiagnostics | MedicalDevices | SmallMolecules | DigitalHealth | |
|---|---|---|---|---|---|---|
| Performance Evaluation Studies | ||||||
| Device Compliance | ||||||
| Clinical Training Services | ||||||
| Clinical Staffing Solutions | ||||||
| Medical Writing | ||||||
| CRO Solutions |
Lab Services
| ATMP | Biotech | In VitroDiagnostics | MedicalDevices | SmallMolecules | DigitalHealth | |
|---|---|---|---|---|---|---|
| iATMP QP batch release | ||||||
| QP Release and EU Import | ||||||
| Stability Studies | ||||||
| Environmental Monitoring Services | ||||||
| Microbiological Analysis | ||||||
| Cleaning Validation | ||||||
| Analytical Method Validation | ||||||
| Chemical Analysis |
Software Solutions & Services
| ATMP | Biotech | In VitroDiagnostics | MedicalDevices | SmallMolecules | DigitalHealth | |
|---|---|---|---|---|---|---|
| E-Labeling / eIFU | ||||||
| Scilife |
Business & Communications
| ATMP | Biotech | In VitroDiagnostics | MedicalDevices | SmallMolecules | DigitalHealth | |
|---|---|---|---|---|---|---|
| Strategy, Commercialization, Operations | ||||||
| Marketing & Communications |