Regulatory Writing Quality Control Services
Ensure accuracy, compliance, and clarity with our experts.
High-quality, error-free regulatory documents are essential for successful health authority submissions. At QInscribe, our Regulatory Writing Quality Control (QC) service offers a rigorous, independent layer of review for your clinical and regulatory documents for those who are already creating their own documents internally. Our QC services ensure scientific data accuracy, regulatory compliance, and internal consistency.
Our experienced QC experts use comprehensive QC checklists, verify content against available data sources, and assess consistency within and across documents. This meticulous process reduces the risk of submission delays, agency queries, or post-submission corrections.
Gain Full Confidence with Expert QC Services
Our QC specialists provide thorough, independent reviews to ensure your clinical and regulatory documents are accurate, compliant, and submission-ready.
- Independent Document Review
Objective and detailed QC of key documents such as Clinical Study Reports (CSRs), clinical study protocols, Investigator’s Brochures (IBs), regulatory summaries (CTD Module 2), patient narratives, Informed Consent Documents (ICDs), and more. - Comprehensive Consistency Checks
Line-by-line cross-checking of key elements (e.g., subject data, tables, figures, endpoints) with source documents, and internal consistency validation across sections, annexes, and related submissions. - Compliance Verification
Meticulous review ensuring adherence to global standards (ICH-GCP, FDA, EMA etc.), including structure, language, and scientific integrity. - Flexible and Scalable QC Services
Customised standalone QC support tailored to meet the needs of your individual projects, timelines, and organisational standards. Whether you need end-to-end QC across a full submission suite or targeted support for individual deliverables, our QC solutions can be tailored to your timelines, standards, and document volume.
What You Gain by Partnering with QInscribe
Confidence in Regulatory Submissions
We ensure strict adherence to global regulatory standards (ICH, FDA, EMA, MHRA, PMDA), and apply industry-aligned best practices for formatting, content integrity, and language precision.
Faster Turnaround Without Compromise
Proactive error identification reduces the risk of regulatory rejections, clarifications, or costly resubmissions. Accurate and compliant submissions streamline the regulatory review process, facilitating faster approval.
Less Administrative Burden
Our reviewers cross-verify information in your documents against available source materials, such as statistical outputs, case report forms, safety listings, etc, to detect and resolve discrepancies at the source.
Clear, Persuasive Communication
We enhance readability, coherence, logical flow, presentation, and overall effectiveness, making your documents more accessible and persuasive to reviewers.
A Scalable Solution
Support one document or an entire portfolio – our services flex around your needs and timelines.
Let’s simplify your path to submission.
Talk to us about your upcoming QC needs and how we can reduce pressure on your internal team, while keeping your trial timelines on track.