Medical Device & Pharma
Regulatory & Quality
Regulatory support and ability to transform to regulations changes, submissions and deliver with Quality.
Insight-driven approach with an integrated Product record and reusable structured building blocks for clinical reporting.
Intelligence and automation solution approach by leveraging proven, modern technology.
Digital Regulatory & Integrated Product Record
Build an intelligent and connected enterprise that enables better and faster product submissions to meet regulations and enable faster distribution.
- Regulatory Information Management process
- Integrated UDI process and submission engine
- Shipping controls based on regulatory approvals
- Integrated Product with IFUs/eIFUs, DHF/DMR information
- Harmonized Design & Doc control with CAPA, Non-Conformance (NC), Complaints and Audits traceability
- End to end Product Lifecycle Management
Data Analytics & Systems Engineering
Enable a data-oriented organization for better traceability and informed decisions.
- Data Exploration and Analysis
- Data intelligence by leveraging Machine Learning (ML)
- Data Migration
- Cloud/Enterprise Application Integration
Cloud for Medical Devices
Scale business solutions to achieve the full potential of a cloud-based architecture.
- Business case for cloud-based strategy
- On-Prem to cloud migrations
Take the Next Step
Connect with us to learn more about our process and services. Together, we can determine which services align best with your objectives.