Consultancy for 
Electronic Document Management 

Regulatory Affairs Systems 
 

OUR CLIENTS

Pharmaceutical companies
Biotech companies
Regulatory Affairs service providers
CROs

OUR SKILLS 

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