Quality Check and Medical Review of Regulatory Documents - Overview
Documentation review is a process where it enhances the accuracy and quality of the document through multiple stages of review. It requires much concentration and focus to maintain the quality of the document to be in line with Regulatory requirements.
Quality checking of Regulatory documents is crucial to ensure document content, style, and format are of high quality. Medical Writers use scientific and research expertise and make the document precise, brief, and aligned with the Regulatory requirements.
Quality control reviews are performed for every deliverable, in any therapeutic area, using either client checklists or our internal document-specific checklists. We follow client-specific style guides/internal style guides for each Regulatory document to ensure quality and consistency within and across the documents.
Medical writers ensure that the document is well-formatted and has a consistent style with quality checks.
Quality Check and Medical Review of Regulatory Documents
- Highly experienced quality reviewers to perform quality control of Regulatory documents
- Systems, processes, and checklists are in place for quality review of medical writing document
- Medical writers and reviewers are well-versed with Medical Writing style guides and Regulatory guidances
- Comprehensive quality reviews are performed for every deliverable
- Flexibility of reviewers/medical writers to work with varied client processes, systems, style guides
- Successfully performed quality reviews across therapeutic areas including but not limited to oncology, cardiovascular, neurosciences, cardiometabolic, immunology etc.
