Automating Study Reports in Pharma: A Technical Guide
Explore document automation for pharma. Learn how template-driven assembly and structured content, inspired by the tech sector, can cut authoring time for study
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Articles tagged with “medical-writing”
AI for IND & CTA Drafting: Benefits, Risks & Compliance Guide
Learn how generative AI and LLMs assist in drafting pharma IND & CTA submissions. This guide explains the benefits, risks, GxP compliance, and FDA/EMA guidance.
USPI Highlights: A Guide to FDA Drug Labeling Requirements
Learn to write the Highlights of Prescribing Information (HPI). This guide covers FDA labeling requirements, the Physician Labeling Rule (PLR), and best practic
PLLR for Biologics: Drafting Clear Pregnancy Risk Summaries
Learn how the FDA's PLLR replaced old pregnancy categories. This guide explains how to draft clear pregnancy risk summaries for complex biologics with limited d
NLP for Prescribing Information: An Evidence-Based Review
An evidence-based review of NLP in regulatory labeling. Learn how AI assists medical writers in drafting Prescribing Information (PI/SmPC) and its limitations.
Medical Writing & Publication Planning: An Industry Guide
Learn about the medical writing and scientific publication planning industry. This guide covers market size, key services like regulatory writing, and GPP guide