Articles tagged with “regulatory-affairs”

Explore how GenAI helps manage pharmaceutical labeling. Learn to draft local label deviations from a CCDS and understand AI's role in regulatory compliance.

Learn how Veeva's Label Concept Tracking in Vault RIM automates pharmaceutical labeling, manages local deviations, and replaces error-prone country tracker spre

Who owns pharmaceutical proofreading? This analysis explores the roles of artwork, regulatory, and QA teams in the pharma labeling workflow to prevent costly er

Learn the end-to-end pharmacovigilance process for translating safety signals into drug label updates. This guide explains CCDS and how Vault Signal accelerates

Explore the career path from a Regulatory Affairs Generalist to a specialized Labeling Strategist. Learn the key skills, role differences, and industry trends.

A guide to the Target Product Profile (TPP), a strategic document for drug development. Learn its components, purpose, and how to align it with the final drug l

Learn why Structured Product Labeling (SPL) is replacing PDF for pharma labeling. This guide explains the FDA mandate, XML standards, and how SPL ensures data i

Explore the regulatory process for negotiating an FDA boxed warning on drug labeling, from initial NDA review to post-market Safety Labeling Changes (SLCs).

Learn to write the Highlights of Prescribing Information (HPI). This guide covers FDA labeling requirements, the Physician Labeling Rule (PLR), and best practic

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

An evidence-based review of NLP in regulatory labeling. Learn how AI assists medical writers in drafting Prescribing Information (PI/SmPC) and its limitations.

Learn how simple pharmaceutical translation errors in an SmPC or patient leaflet can lead to major drug recalls, regulatory sanctions, and patient safety risks.

Explore a structured cascade model for rolling out pharma safety labeling updates to global affiliates, ensuring regulatory compliance and sub-90-day implementa

Learn the difference between a Company Core Data Sheet (CCDS) and local labels. Explore strategies for managing global labeling deviations for regulatory compli

Learn the key differences between ISO 14155 for medical device trials and ICH GCP for pharma. This guide compares their scope, risk management, and regulatory c

Learn what an Investigator's Brochure (IB) is, its required content per ICH GCP guidelines, and its critical role in assessing risk for clinical trials.

Learn about the EU Clinical Trial Regulation (CTR) 536/2014 and the CTIS portal. This guide covers harmonized submission processes, key timelines, and transpare

An in-depth comparison of the FDA and EMA. Learn the key differences in US and EU drug approval processes, review timelines, GMP, and regulatory frameworks.

Explore a comprehensive list of the top pharma news websites and biotech publications. Learn about sources for drug development, regulatory changes, and market

Understand the FDA 510(k) premarket notification process for Class II medical devices. This guide covers substantial equivalence, predicate devices, and key ste

Learn about the most in-demand pharma roles for 2025. This analysis covers top pharmaceutical jobs in AI, advanced manufacturing, and clinical development.

An in-depth guide to Veeva Vault RIM. Understand the core modules like Submissions & Registrations and its role in modern Regulatory Information Management.

An educational guide to Regulatory Information Management (RIM) systems and their role in adopting ISO IDMP standards for life sciences compliance and data inte

A guide to finding drugs in the clinical pipeline (Phase I-III). Learn to use key resources like ClinicalTrials.gov, regulatory databases, and commercial tracke

Learn about Veeva Vault RIM, the leading regulatory information management platform. This guide covers its features, architecture, market adoption, and ROI with

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.