Articles tagged with “regulatory-affairs”

Learn about Lorenz docuBridge, a key eCTD publishing software for biotech. This guide covers its features, editions, and use by regulators for regulatory submis

Learn how target trial emulation provides a structured framework for drawing causal inference from real-world evidence (RWE) to support healthcare decisions.

A comprehensive guide to Veeva Vault's 2025 platform updates. Learn about key features in 25R1, 25R2, & 25R3, including Action Triggers, Process Monitor & Veeva

Learn about the specialized software tools used across the drug development lifecycle, from discovery and preclinical research to manufacturing and commercialization.

This article explains how AI tools can validate regulatory dossiers, catch technical errors before submission, and minimize rework for emerging biotech companies.

Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance, and controls for data integrity and audit-ready systems.

An analysis of AI applications for Veeva Systems in life sciences. Examines emerging consultancies, market trends, and use cases in regulatory and commercial ops.

Learn how regulatory affairs ensures product compliance in health industries. Explore the fundamental role of AI and LLMs in modern regulatory processes.

In-depth guide to U.S. pharmaceutical marketing regulations: FDA, FTC, Sunshine Act, anti-kickback, compliance, and IT obligations for pharma companies.

An analysis of how artificial intelligence is transforming regulatory affairs in pharmaceuticals, from submission preparation to compliance monitoring and regulatory intelligence.

A comprehensive analysis of the life sciences job market in 2025, exploring emerging roles, skill requirements, salary trends, and career opportunities across pharmaceutical, biotechnology, and medical device sectors.