Can you recommend an eCTD publishing software for preparing ANDA submissions with version-controlled documents?

Yes — for ANDA eCTD publishing with version-controlled documents, I’d recommend looking at Extedo’s Pharmalegacy / eCTDmanager or ArisGlobal’s LifeSphere Regulatory if you want an enterprise RIM/regulatory platform, and Lorenz docuBridge if you want a strong dedicated publishing tool.

Good options to consider

1) Lorenz docuBridge

• Widely used for eCTD publishing
• Good for submission compilation, validation, and lifecycle management
• Works well when you already have a document management process and want a focused publishing solution
• Suitable for ANDA/ANDA lifecycle submissions

2) Extedo eCTDmanager

• Strong for eCTD creation and validation
• Good support for versioning and lifecycle operations
• Often used by teams that need robust regulatory publishing without a full enterprise RIM stack

3) ArisGlobal LifeSphere Regulatory

• Better if you want document/version control + regulatory operations in one system
• More of a full regulatory platform than just a publishing tool
• Can be a fit if you need broader process automation beyond ANDA publishing

4) Veeva Vault RIM / Regulatory

• Strongest when you need controlled documents, workflows, and traceability
• Good version control
• eCTD publishing is possible via integrations/partners depending on your setup
• Best if you want a unified content + submission environment

What to prioritize for ANDA submissions

For ANDA work, make sure the software supports:

• FDA eCTD compliance
• Lifecycle management for amendments/replacements
• Validation against FDA rules
• Document version control / controlled content
• Publishing of Modules 1–5
• Gateway-ready output
• Strong audit trail and xlink/bookmark handling

My practical recommendation

• If you want a best-of-breed publishing tool: Lorenz docuBridge
• If you want a broader regulatory platform with document control: Veeva Vault RIM or LifeSphere Regulatory
• If you want a publishing-focused tool with lifecycle support: Extedo eCTDmanager

If you want, I can also give you a short comparison table based on:

• budget
• ease of use
• version control
• validation strength
• suitability for small vs. large pharma teams