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SopReg Consulting Services
Regulatory Submissions
Regulatory Submissions
- Submission planning & Timelines
- Project & Content Plan
- Document Preparation
- Compliance Assurance
- Cross-functional coordination
- Content management
- Technical Validation
- Submission Compilation
- Lifecycle management
- Agency Communication
eCTD Publishing
Regulatory Submissions
- Submission Readiness
- Document Formatting
- Validation Checks
- Lifecycle management
- Granularity Compliance
- Metadata Management
- Submission Compilation
- Technical Expertise
- Global Submission Support
- Version Control
- Regulatory Timelines
- Submission Tracking
Regulatory Training & Guidance
- Regulatory compliance workshops
- Document formatting training
- eCTD lifecycle management tutorials
- Regulatory Landscape
- Submission Process Training
- Document Compliance
- Health Authority Expectations:
- eCTD Tools and Software
- Lifecycle Management:
- Technical Validation
- Cross-functional Collaboration:
- Common Pitfalls: I
- Agency Communication
- Mock Submissions
- Tailored Guidance
Content Validation
Post Submission Support
- Automated Validation Tools
- Manual review by experts
- Error resolution support
- Regulatory Compliance
- Formatting Standards
- Content Consistency
- Metadata Accuracy
- Structure Validation
- Technical Checks
- Version Control
- Alignment with Granularity
- Regulatory Templates
- Data Integrity
- Cross-referencing
- Final Review
Post Submission Support
Post Submission Support
Post Submission Support
- Agency Correspondence
- Submission Tracking
- Query/Deficiency Responses
- Amendments and Supplements:
- Compliance Monitoring
- Document Updates/ Amendments
- Change Management
- Audit Readiness
- Post-Approval Maintenance
- Feedback Integration:
- Global Support
RIMs Implementation
Post Submission Support
Post Submission Support
- System Evaluation and Selection: Assistance in choosing the right RIM solution for your organization.
- Configuration and Customization: Tailored setup to meet your regulatory and operational needs.
- Data Migration: Seamless transfer of legacy data to the new RIM system.
- Training and Change Management: Ensuring teams are equipped to leverage the full potential of the RIM platform.
- Ongoing Support: Continuous optimization and troubleshooting to ensure system effectiveness.