Pharmaceutical companies
Biotech companies
Regulatory Affairs service providers
CROs
e-DRA Harmsen implements R&D IT systems:
• Electronic Document Management
• eSubmission / eCTD
• Regulatory Information Management (RIM) / xEVMPD
• other R&D IT Systems
e-DRA Harmsen offers R&D IT services:
• write User Requirements
• facilitate system selection
• plan and coordinate project
• validate computer system according to GAMP 5
• negotiate and manage contracts / SLAs with software and data center vendors
• develop R&D IT strategies
• manage IT integration during mergers
• interim manage regulatory operations and document management departments
e-DRA Harmsen Customers are:
• Pharmaceutical companies
• Biotech companies
• Regulatory Affairs service providers
• CROs
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