Regulatory Support
Through local regulatory expertise worldwide, MDCE facilitates
- Clinical Trial Applications
- Procedure Management
- Authority Interaction
- Regulatory Operations
- Product Registrations
- China
- United States
- Canada
- European Union
- Australia
- Japan
- South Korea
- Latin America
- Middle East & Africa
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Clinical Development
MDCE’s expertise in clinical development improves clinical trial performance and accelerates clinical trials with
- Clinical Strategy
- Synopsis Development
- Protocol Development
- Investigator Outreach
- Site Feasibility
- Site Contract
- EC Approval
- Site Initiation
- Monitoring Visit
- Close Out Visit
- Project Management
- Vendor Management
- Timeline Management
- Data Management
- Biostatistics
- Study Report
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Feasibility Assessments
Building a foresight before investing time and money in a project helps achieve faster identification of challenges and possible solutions
- Regulatory Assessment
- Product Assessment
- Study Assessment
- Hospital Assessment
- Vendor Assessment
- Vendor Selection
- Investigator Selection
- Distributor Selection
- General Consultation
- Ad Hoc Consultation
- KOL Meeting
- GCP Audit
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