Automating global regulatory submissions without disrupting enterprise systems

Introduction

Replacing manual regulatory workflows with scalable, governed enterprise automation.

A global healthcare manufacturer operating across multiple regions was facing a new regulatory requirement to produce submission forms to meet updated compliance rules within a fixed deadline. These forms, containing global packaging information, were being created manually using extensive copy‑and‑paste from structured data sources into standardised templates. This approach was time‑consuming, difficult to scale, and introduced significant compliance risk at a point when accuracy and timeliness were critical.

The organisation engaged Altuent to assess how automation could be introduced to meet the new regulatory requirements efficiently, reduce risk, accelerate delivery, and operate fully within existing enterprise systems and AI governance constraints.

The Challenge

Manual regulatory documentation relied on copy‑paste and hand‑typing, increasing error risk

The client’s teams were responsible for producing complex regulatory submission forms for multiple products across global markets. Each submission required repetitive manual copy‑and‑paste from approved data sources, followed by detailed human review. Errors in packaging data posed a genuine regulatory risk, while the manual nature of the work limited speed and consistency. Although the organisation was proactive about AI, any solution had to comply with strict internal governance, avoid disruption, and deliver fast, tangible value.

Key challenges identified

• Limited ability to reuse effort across similar regulatory projects
• Entirely manual copy‑and‑paste across products, countries, and submissions
• High regulatory risk if packaging data was entered incorrectly
• Significant time spent on repetitive, low‑value documentation tasks
• Manual review cycles slowing submission timelines

Our approach

Pragmatic automation aligned to enterprise governance and real workflows

Altuent began with detailed discovery to understand the regulatory process, data sources, and governance constraints. The client had requested a GenAI solution, we tested that, alongside automations and ended up with automation rather than GenAI.

We designed a multi‑step automation that transformed approved structured data into compliant regulatory forms, integrating with existing systems rather than replacing them. The solution prioritised accuracy, auditability, and reuse, with a clear handover to internal data engineering teams.

• Discovery focused on regulated workflows and operational constraints
• Designed multi‑step automation for structured regulatory form generation
• Operated fully within existing enterprise systems and AI governance
• Prioritised accuracy and traceability
• Collaborated closely with internal teams throughout delivery
• Built quality checks to make sure we were automating correctly
• Enabled handover and reuse of automation logic internally

Delivered value quickly without disrupting ongoing operations

The results

Reduced manual effort, faster submissions, less error, and lower regulatory risk

The automation replaced a fully manual documentation process with a governed, repeatable workflow. Regulatory submission forms were generated more quickly and consistently, significantly reducing copy‑and‑paste effort and associated risk. The solution was used for the initial project, and we handed over the automation logic, creating a foundation for future automation opportunities.

• Substantial reduction in time spent creating regulatory submission forms
• Significant decrease in manual copy‑and‑paste and review effort
• Improved consistency and accuracy across global documentation
• Faster turnaround against regulatory submission deadlines
• Automation logic shared with potentiel for it to be used on multiple subsequent projects