Articles tagged with “lifecycle-management”

eCTD Validation Errors: A Guide to Avoiding RTF

Learn the most common eCTD validation errors that cause Refuse-to-File (RTF) actions. This guide covers structural, XML, and PDF issues for successful submissio

35 min read

1/14/2026

ectd ectd validation errors regulatory submission refuse to file fda regulatory affairs xml backbone lifecycle management

Patent Cliff Strategy: Role of Competitive Intelligence Software

Learn how pharma firms use competitive intelligence software to mitigate patent cliff risks. We analyze strategies for managing drug patent expiration and reven

35 min read

1/9/2026

competitive intelligence patent cliff loss of exclusivity pharma strategy ci software biosimilar competition drug patent expiration lifecycle management