Articles tagged with “pharmaceutical-compliance”

Global Regulatory Submissions: ICH vs Regional Rules

Analyze global regulatory submissions, contrasting ICH guidelines with regional requirements. Learn to manage FDA, EMA, and local filing differences.

35 min read

2/2/2026

regulatory submissions ich guidelines ectd format global regulatory affairs pharmaceutical compliance ctd dossier fda vs ema drug registration

Off-Label Promotion: A Compliance Guide for MSL Teams

Learn the FDA regulations for off-label promotion and how MSL teams can maintain compliance. This guide covers USPI boundaries and best practices for scientific

40 min read

11/22/2025

off-label promotion msl compliance medical affairs fda regulations uspi scientific exchange pharmaceutical compliance

Pharmaceutical Compliance Software: A Guide to QMS & GxP

An in-depth analysis of pharmaceutical compliance software for GxP and QMS. Learn key features for 21 CFR Part 11 and compare top vendors like Veeva & MasterCon

60 min read

11/13/2025

pharmaceutical compliance qms software gxp compliance 21 cfr part 11 data integrity pharmacovigilance capa management veeva vault

GAMP 5 Categories Explained: Software, Risk & Examples

Learn the GAMP 5 software categories for computerized system validation. This guide explains each category with examples and its role in a risk-based approach.

25 min read

10/16/2025

gamp 5 computer system validation gxp risk-based approach ispe software validation pharmaceutical compliance

Computer System Validation in Pharma & Biotech Compliance

Learn what Computer System Validation (CSV) is, its crucial role in pharmaceutical and biotech compliance, ensuring data integrity and regulatory adherence for patient safety.

60 min read

5/30/2025

computer system validation csv pharmaceutical compliance biotech compliance fda regulations data integrity gxp 21 cfr part 11