Strategic Regulatory Narratives
A well-authored regulatory dossier is the foundation of every successful submission. It's not merely a collection of documents—it's a strategic narrative that guides reviewers through your product's quality, safety, and efficacy profile.
RegOps brings together scientific writers, regulatory strategists, and subject matter experts who understand what health authorities need to see. We author dossiers that are complete, consistent, and constructed to facilitate efficient review. From initial planning through final QC, every module is crafted to support your regulatory objectives and prevent review delays.
Our Capabilities
Comprehensive authoring for all dossier modules.
Expert authoring of Quality, Nonclinical, and Clinical Overviews and Summaries (2.3 - 2.7). We synthesize complex data into clear, reviewable narratives.
Development of complete Module 3 content including drug substance/product specs, manufacturing descriptions, analytical procedures, and stability data presentation.
Comprehensive support for Modules 4 & 5, including study reports and integrated summaries. We ensure scientific accuracy and regulatory alignment.
Market-specific administrative documentation including cover letters and application forms. We maintain templates aligned with FDA, EMA, and other HA requirements.
Critical review of existing dossier content to identify gaps or inconsistencies. We provide actionable recommendations and can execute remediation work.
Rapid authoring support for Information Requests and Complete Response Letters. We help you respond thoroughly and strategically within tight timelines.
The RegOps Advantage
Our writers speak the language of your data and translate it effectively for regulatory audiences.
Scientific Depth
Our writers hold advanced degrees in pharmacology and clinical sciences, ensuring accurate translation of technical data.
Template Libraries
We maintain current, agency-aligned templates for every section, reducing development time and ensuring compliance.
Collaborative Workflow
We integrate seamlessly with your internal teams, maintaining transparent communication and tracking to keep projects on schedule.
Quality Assurance
Every deliverable undergoes multi-level review including scientific accuracy, regulatory alignment, and formatting polish.