Simplify Planning to Publishing with Unified Submission Content Plans

Jul 25, 2025 | Alison Marjanowski

Regulatory teams face increasing pressure to be agile, simultaneously managing submissions of varying size and complexity while meeting evolving global health authority (HA) requirements. However, siloed systems often hinder visibility into submission data and progress. Submission content plans (SCPs) that are part of a unified RIM solution provide a “central hub” for planning, real-time tracking, and managing submission development across teams and markets. With data flow across a single platform, SCPs can seamlessly manage continuous publishing automation.

Moving from fragmented to unified SCP data and processes on an end-to-end RIM platform, regulatory teams can simplify submission management, maintain compliance, and drive operational efficiency.

Managing submissions across siloed systems

Submissions are typically managed through spreadsheets, emails, and file shares, with roles and responsibilities assigned on a case-by-case basis. Routine submissions might be handled independently with little process oversight while larger, complex submissions may involve greater planning and collaboration.

While submission management varies depending on company size, maturity, or resources, many regulatory teams face similar challenges organizing SCPs using fragmented systems:

• Compliance risk: Siloed systems and processes are prone to version control issues, data entry errors/omissions, and poor oversight
• Limited transparency: Lack of real-time global visibility into individual document and submission progress hinders accurate reporting, decision-making, and metric tracking
• Inefficient processes: Highly manual and duplicative work slows communication, task delegation, content development, and consensus building, limiting flexibility to scale submission volume or complexity

Siloed systems also make collaboration challenging between teams like quality and regulatory, who have difficulty identifying current data and documents. The inefficiencies undermine efforts to streamline submission lifecycles and increase the risk of delaying delivery of medicines and therapies to patients.

Centralizing and unifying submission content and processes

Adopting an end-to-end platform early on for submission content and processes provides several advantages for both the business and end user. For instance, Bayer unified content plans with its end-to-end RIM system, gaining enhanced visibility and traceability of submission processes both centrally and for local affiliates. This central hub approach reduces the number of systems, databases, and communication channels for managing submission content plans, enabling:

• Global traceability of all submission data, documents, and versions
• Real-time reporting of process status, assignments, and progress to inform critical decisions
• Easier compliance with regional HA guidelines by leveraging content plan templates and constraints
• Increased agility for responding to internal and external change, including new regulations and preparation for innovation like generative AI

A central hub also provides content plan owners with improved control over submission development. They can confidently plan, track, and manage submissions while restricting or catching any post document approval changes. User-specific views can be easily configured to only display the most relevant parts to specific user groups as needed. This supports both new and experienced users with standardized best practices to minimize manual rework, email Q&As, and confusion.

Streamlining submission preparation on a unified platform

Veeva submission content plans, a key capability of Veeva RIM, simplify and streamline submission lifecycles by unifying content and processes on a single, collaborative, and data-centric platform. A centralized approach to managing submission development significantly increases overall efficiency from planning to publishing, while providing global visibility into submission statuses.

Key benefits of Veeva SCPs include:

Veeva SCPs are flexible and changeable at any point, allowing plans to start even if all submission details are not finalized. And with an open API, organizations can seamlessly integrate external tools like SmartSheet without compromising the SCP as the single source of truth.

Maximizing platform value with continuous publishing

Veeva SCPs are key to maximizing the value of a unified RIM platform and setting the foundation for innovative features like “where submitted” document-level reporting, global content plans (GCP), active dossier, and continuous publishing.

Veeva SCPs is the central management point for the entire publishing process in Veeva Submissions Publishing. This capability combined with continuous publishing — where downstream publishing and validation tasks run in parallel with upstream planning and authoring — significantly accelerates submission preparation and delivery. Once complete, the draft publishing output is automatically staged in Veeva Submissions Archive.

When using an external publishing vendor, Veeva SCPs also support full structure and content exports with manual archiving in Veeva Submissions Archive. Trusted vendors can be given direct access to pull their own plans and documents, as well as upload the final submission to Veeva Submissions Archive.

Best practices for Veeva SCPs include:

• Designate a submission content plan owner to actively define fields, assign tasks, and monitor submission progress
• Lock final documents to minimize confusion, rework, and errors. Use reporting to check for any post document approval changes
• Encourage proactive data entry of drug substance, manufacturers, indications, etc. from users to ensure downstream data quality when using submission wizards
• Create custom user views to keep team members focused on relevant data and priorities

Join us at the 2025 Veeva R&D and Quality Summit in Boston to learn more about streamlining regulatory processes, fostering a data-driven culture, and speeding products to market.