The success of any clinical development program relies on the quality of documentation presented to regulatory agencies. Our scalable and flexible solutions allow you to focus on content, data, and messaging while we handle the technical details.
Document Quality and Management Services
Ensuring accuracy, compliance, and efficiency
Certara’s document quality and management services empower sponsors to deliver consistent, accurate, compliant with regulatory agencies requirements, and efficient regulatory submissions.
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Streamline your regulatory submissions with Certara
Quality Control (QC)
We perform comprehensive QC reviews, including content verification, editorial checks, and formatting, ensuring your documents are submission-ready.
Document-level formatting
Efficient formatting aligns your documents with agency requirements for smoother reviews and faster approvals.
Document-level publishing
We ensure submission readiness and eCTD compliance by addressing validation errors and optimizing technical and navigational elements.
Style guide and template support
Our standardized tools streamline document creation, ensuring consistency and efficiency across your submissions.
Certara’s innovative approach to Document Management
Our Document Quality services
Quality control
Thorough review processes for accurate and compliant submissions.
Document formatting
Streamlined formatting for regulatory compliance.
Publishing solutions
Submission-ready publishing support for eCTD compliance.
Template support
Standardized templates for efficient document creation.
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Let Certara’s Document Quality team help you streamline your regulatory submissions with our proven expertise and innovative solutions. Whether you need comprehensive QC, formatting, or publishing support, we are here to assist and ensure your success.
Proven expertise in regulatory document management
Comprehensive support tailored to your needs
A trusted partner for global regulatory submissions
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Frequently asked questions
How does Certara ensure document compliance?
Our team follows detailed SOPs and regulatory guidelines to deliver accurate, submission-ready documents.
Can Certara support urgent or high-volume requests?
Yes, our global team offers scalable solutions to meet tight timelines and large-scale demands.
What are eCTD Authoring Templates?
These are standardized tools designed to streamline document creation and ensure regulatory compliance.
Do documents written by Certara go through a quality control process, or is it an additional item?
Yes, all documents authored by Certara are rigorously reviewed through our comprehensive QC process, which is included as part of our service to ensure accuracy, consistency, and compliance with regulatory standards.
