Submission-Ready Reports, Every Time
Our dedicated Document Production team delivers high-quality, eCTD conformant reports that meet regulatory standards and accelerate your path to submission.
The Reporting Challenge
Regulatory submissions demand flawless documentation, but creating submission-ready reports is complex and time-intensive.
Quality Control Bottlenecks
Multiple review cycles, inconsistent formatting, and quality control delays can extend timelines and jeopardize submission deadlines.
eCTD Compliance Complexity
Ensuring documents meet eCTD guidelines with proper bookmarks, internal links, and searchable formatting requires specialized expertise.Resource Constraints
Your scientific team’s time is better spent on research and analysis, not wrestling with document formatting and regulatory requirements.
Your Document Production Experts
Our Expertise
- Report and document writing
- Report quality control checking
- Document level eCTD publishing
- eCTD publishing quality control
- Template preparation and maintenance
- Regulatory guidelines compliance
- Microsoft Word and Adobe Acrobat Pro mastery
Dedicated team structure
- Senior Report Writers
- Report Writers
- Publishers
- Document Quality Associates
Our Streamlined Process
We’ve refined our process to deliver high-quality, submission-ready reports efficiently and reliably.
Tangerine steps are completed by our Document Production Team
Experimental End
Study completion and data finalization
Report Writing
Expert writers craft comprehensive reports
QC Checking
Rigorous quality control review
Audit & Review
Report audit and sponsor review
eCTD Publishing
Final eCTD-compliant formatting
Target Timeline Achievement
Through continuous process improvements, we’re working toward:
Tailored Service Options
Project Report
Complete reports using Resolian’s standard template and house style formatting, ready for regulatory submission.
Project Summary Report
Streamlined summary reports using our standard template. Perfect for non-regulated, exploratory projects requiring data presentation.
Sponsor-Specific Reports
Reports customized to your exact requirements using your templates or our templates adapted to your specifications.
eCTD Publishing
Expert eCTD formatting with proper bookmarks, internal links, and searchable documents to ensure submission readiness.
Your Outcomes
FASTER TIME TO SUBMISSION
Accelerate your regulatory timeline with our efficient 8-week target from study completion to draft report.
First-Time Compliance
Eliminate revision cycles with reports that meet eCTD guidelines and regulatory standards from the start.
Focus on Core Science
Free your scientific team to focus on research while we handle the complexity of document production.
reduced risk
Minimize submission delays and regulatory queries with professionally prepared, quality-assured documentation.
