Nearshoring Services

Our Nearshoring Expertise
Supported by expert technical leadership with 15+ years of experience in development and infrastructure, our Nearshore model offers DeWinter's same trademark quality of service with added flexibility, efficiency, and instant access to expert talent.
Clinical
- Trial Management
- Program Management
- Data Management
- Bioinformatics/Biostatisticians
- Medical Writers
Validation
- Validation Master Plan
- Process & Equipment Validation
- Computerized Systems & Automation Validation
- Test Method Validation
- Software Validation
- Qualification for all phases of the lifecycle (DQ/IQ/OQ/PQ)
- SOPs
Quality Assurance
- Change Control
- Quality Management Systems Transformation
- Risk Assessment
- Standards Compliance
- Test Methods and Controls
Regulatory Affairs/Compliance
- EU MDR & IVDR
- Adverse Event Reports
- Inspection Readiness
- 501(k) and Controls Submissions
- RIMS
Manufacturing
- Production & Process Improvement
- SOP Creation & Technical Writing
- Technology Transfer
- MES
Technology Solutions
- ERP & MRP
- MES
- LIMS
- Data Integrity
- Cybersecurity
- Automation & Controls
- Enterprise Applications
- Technical Writing
Project Controls
- Project Scheduling
- Cost Controls
- Project Management

Our Life Sciences Talent Solutions
With over 15 years of industry experience, our Life Sciences team creates expert, specialized staffing solutions tailored to each stage of your project lifecycle.
Clinical
- Trial Management
- Program Management
- Data Management
- Bioinformatics/Biostatisticians
- Medical Writers
Validation
- Validation Master Plan
- Process & Equipment Validation
- Computerized Systems & Automation Validation
- Test Method Validation
- Software Validation
- Qualification for all phases of the lifecycle (DQ/IQ/OQ/PQ)
- SOPs
Quality Assurance
- Change Control
- Quality Management Systems Transformation
- Risk Assessment
- Standards Compliance
- Test Methods and Controls
Regulatory Affairs/Compliance
- EU MDR & IVDR
- Adverse Event Reports
- Inspection Readiness
- 501(k) and Controls Submissions
- RIMS
Manufacturing
- Production & Process Improvement
- SOP Creation & Technical Writing
- Technology Transfer
- MES
Technology Solutions
- ERP & MRP
- MES
- LIMS
- Data Integrity
- Cybersecurity
- Automation & Controls
- Enterprise Applications
- Technical Writing
Project Controls
- Project Scheduling
- Cost Controls
- Project Management

Ready to Find Expert Life Sciences Support?
Our extensive network of specialized life sciences talent ensures your projects are not only completed on time and on budget, but also deliver game-changing results. Whether you need a Clinical Research Associate for a new trial or a Manufacturing Engineer for process optimization, we provide the precise expertise required to meet your specific goals.
What Our Clients Have To Say
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Solutions With Impact
Find out how our network of top-tier consultants can help meet your needs at any stage.