Articles tagged with “pharma-compliance”

Learn the compliant process for answering off-label HCP inquiries. This guide details FDA guidance, medical information SOPs, and software for case management.

Learn how pharma companies compliantly fund physician education via unrestricted grants. Explore ACCME standards, the Sunshine Act, and firewalls for ethical CM

Learn the key differences between US DSCSA and EU FMD for pharmaceutical serialization. This guide covers compliance requirements for ops teams, including data

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

An analysis of how DocuSign is used for electronic signatures in pharma and life sciences. Learn how it can meet FDA 21 CFR Part 11 compliance with its modules.

Learn the key differences between GAMP 4 and GAMP 5. This guide for pharma IT covers the shift to risk-based validation and provides a clear migration path.

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

A comprehensive guide to Key Opinion Leader (KOL) tiering in pharmaceutical marketing, covering definition, strategic importance, tiering criteria, engagement strategies, and compliance considerations for U.S. pharma companies.