Electronic Common Technical Document (eCTD)
Document templates and template development
Electronic Document Management Systems (EDMS)
Desktop publishing, MS Word remediation, PDF remediation, report publishing
Submission publishing services
eCTD readiness assessment
Submission process development
Submission product planning
Quality control checklists for individual documents and submission sequences
Electronic and paper submissions
Investigational, marketing, and post-marketing submissions
Review and approval
Standard operating procedures
Quality assurance + quality control
EDMS and submission publishing system selection, implementation and management
Computer system validation (IQ, OQ, PQ/UAT)
eCTD validation services using GlobalSubmit Review & Validate