Overview
Multi-disciplined clinical teams who provide robust, GCP and ISO 14155 compliant clinical trials for low risk medical devices.
Expertise
- Medical Devices Clinical Trial Management in Europe
- Biostatistics for Medical Device Clinical Studies
- Medical Devices Clinical Trial Data Management
- Medical Devices Post-Market Clinical Follow-up Studies (PMCF)
- Clinical Research Study Audits of Medical Device
- Clinical Trial Study Design and Protocol Development of Medical Device.
Advantages
- Cost-effective
- End-to-end Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of personal care and cosmetic products like Skincare, Oralcare, Hair care, Baby care and beauty products.
- Expert support for region-specific Regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach to ensure quick product launch or market access
