RegWriter™ simplifies CTD Module 3 authoring
Always a human in the loop
Cutting-edge software solutions for medical device and biopharma professionals
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Collaborative Partnership
Partner to develop software solutions tailored to meet your unique business needs
Streamlined Workflows
Standardize templates and reduce manual effort with AI -augmented authoring
Secure and Scalable
Adapt and grow with confidence as your organization evolves
Our Products
RegWriter™ AI-platform automates authoring, improves efficiency, reduces costs, and simplifies your regulatory submission workflow.
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SmartComplaints™ machine learning model automates categorization of your post-market complaints to MDCG-recommended IMDRF Annex codes.
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