Simplify Submission Planning to Publishing
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.As a feature of a unified RIM solution, submission content plans (SCPs) provide a “central hub” for planning, real-time tracking, and managing submission development across teams, regions, and markets. With data flow on a single platform, SCPs can seamlessly manage continuous publishing automation to accelerate submission delivery.
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 documents 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 restrict teams to traditional publishing models that require content approval before starting publishing tasks and validation, often just days before the submission is due. 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 decision
- 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.
Streamlining submission preparation and delivery 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. 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 can manage the entire publishing process with Veeva Submissions Publishing to significantly accelerate submission preparation and delivery with higher quality documents and messaging. This continuous publishing approach pulls traditionally downstream publishing and validation tasks upstream to run in parallel with planning and authoring. Users can conduct content review and approval in the context of the eCTD output without waiting until the final step. Submission managers can also leverage HA-compliant templates with recommended constraints for both eCTD and non-eCTD formats. These flexible plans can be started even if all submission details aren't finalized, helping enable a more frictionless publishing process. Veeva SCPs and Veeva Submissions Publishing support upcoming requirements like eCTD 4.0 and IDMP, and readily scale to additional regions without additional investment.
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Nader Girgawy is director, Veeva RIM at Veeva Systems