Quality control review: A crucial step in the regulatory writing process
In drug development, a single error in data, formatting, or interpretation can delay approval, damage credibility, or even compromise patient safety. That’s why quality control (QC) review is built into the regulatory writing process.
A thorough QC process includes multiple levels of review, each with a distinct focus:
- Content Verification: The first step in QC review is 100% verification of content. During this process, our QC reviewer will check your document for accuracy against sources such as protocols, study reports, and statistical outputs. This step ensures that all data points and text are reported correctly and consistently throughout the document.
- Language and Clarity Review: Our QC reviewer checks grammar, punctuation, sentence structure, and readability. Ambiguous or inconsistent language is flagged and revised to enhance clarity without altering the scientific meaning.
- Formatting and Style Review: Regulatory agencies and pharma companies have specific formatting requirements. This step in the QC review confirms adherence to your template and style guide, along with verifying consistency in hyperlinks, headings, numbering, tables, and figures. Clean formatting helps your publisher to quickly and accurately prepare the document for submission and ultimately allows reviewers to navigate your document more efficiently.
- Cross-Referencing and Consistency Check: Our QC reviewer checks for internal consistency throughout the document and across related documents. Whether you are drafting a protocol or writing multiple summary documents in parallel, this step is key to ensuring that your documents provide consistent information throughout. Discrepancies can lead to protocol deviations or safety concerns and are red flags for regulators.
Regulatory documents must align with source material while presenting complex data in a clear and accurate manner. QC review acts as the final safeguard, catching discrepancies that might have been overlooked by busy reviewers or hyperfocused writers. At Med Communications, we ensure that QC review is not just an afterthought; it’s built into our process.
A disciplined QC process minimizes risk, boosts reviewer confidence, and ultimately supports faster regulatory approval. For pharmaceutical teams, partnering with regulatory writers who prioritize rigorous QC reviews is a strategic advantage that pays dividends across every phase of drug development.
Our reviewers take pride in applying the same level of precision and expertise to each level of the quality control review process, ensuring that your regulatory documents are clear, accurate, and consistent. To request a capabilities presentation, please contact us at 877-477-0977 or https://medcommunications.com/contact-us/.