Articles tagged with “medical-writing”

AI in Regulatory Writing: Benefits, Risks, and Use Cases

Explore AI in regulatory writing: analysis of drafting efficiency, clinical study reports, and key risks like hallucinations and data privacy compliance.

45 min read

2/14/2026

regulatory writing medical writing generative ai clinical study reports compliance automation ai risk management large language models data privacy

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

40 min read

12/11/2025

document automation pharma documentation structured content medical writing regulatory submissions template-driven assembly docs as code

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.

60 min read

12/9/2025

generative ai regulatory affairs ind submission cta submission medical writing llms in pharma gxp compliance drug development fda 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

40 min read

11/23/2025

drug labeling uspi fda regulations physician labeling rule medical writing 21 cfr 201.57 regulatory affairs

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

50 min read

11/23/2025

pllr pregnancy risk summary biologics fda labeling drug safety regulatory affairs monoclonal antibodies medical writing

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.

50 min read

11/23/2025

natural language processing regulatory labeling generative ai prescribing information medical writing smpc large language models regulatory affairs

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

30 min read

11/16/2025

medical writing publication planning regulatory writing gpp guidelines clinical trial publications scientific communications cro services