Digital Operations

In today’s increasingly complex and fast-paced pharmaceutical landscape, the transition to digital regulatory operations is no longer optional — it is a strategic necessity.

Digital Regulatory Operations Consulting for a Future-Ready Regulatory Affairs Function

As Regulatory Affairs becomes increasingly digital and data-driven, pharmaceutical companies are under pressure to modernize systems, structure data, and ensure compliance with evolving standards like IDMP, XEVMPD, and SPOR. At Arithmos, we help Regulatory Affairs departments shift from fragmented or document-centric models to connected, intelligent digital operations — ready to support both current business needs and future regulatory demands.

Our consulting services bridge the gap between business, IT, and compliance — enabling a holistic transformation of your digital regulatory ecosystem.

How Arithmos Consulting Supports Digital Regulatory Operations

RIM Solution Evaluation, Reorganization & Extension

Your Regulatory Information Management (RIM) system is the foundation of digital regulatory operations.
We support companies in:

• Assessing current RIM capabilities and identifying functional gaps
• Designing reorganization plans to improve usability, data quality, and business alignment
• Defining extension roadmaps to add modules (e.g., submission tracking, health authority correspondence, IDMP support)
  Whether you’re optimizing an existing platform or preparing for a new solution, our technology-agnostic approach ensures your RIM investment delivers long-term value.

Data & Document Management Design (Beyond Regulatory)

Digital regulatory operations require more than good RIM — they require a connected ecosystem of high-quality data and controlled documentation.
We help clients:

• Design cross-functional data models that integrate Regulatory, Quality, Safety, and Clinical
• Define taxonomy, metadata, and governance frameworks for structured content management
• Establish validated document workflows aligned with GxP and 21 CFR Part 11
  This approach reduces duplication, improves traceability, and supports submission readiness, inspection readiness, and global collaboration.

XEVMPD / IDMP / SPOR Readiness Assessment (for Medicinal and Investigational Products)

With regulatory agencies pushing toward structured data submissions, companies must assess their readiness to comply with complex data standards.
Arithmos provides:

• Gap assessments against EMA IDMP/SPOR and XEVMPD requirements
• Mapping of existing data sources (RIM, ERP, DMS, spreadsheets)
• Evaluation of data ownership, stewardship, and governance structures
• Identification of impacted products and critical data elements (e.g., substance, manufacturer, packaging)
  This service helps you build a risk-based, prioritized plan for becoming compliance-ready — while aligning with your existing systems and business processes.

XEVMPD / IDMP / SPOR Compliance Implementation Design

Once the gaps are known, the challenge becomes how to close them in a scalable, sustainable way.
Arithmos supports clients in:

• Designing target data models and integration architectures
• Defining processes, roles, and responsibilities for compliant data entry and maintenance
• Preparing business requirements for system configuration or upgrades
• Supporting vendor selection or coordination with your existing technology providers
  Our deep regulatory knowledge ensures that your implementation is not just technically sound — but regulatory fit-for-purpose, auditable, and future-proof.

Why Choose Arithmos for Digital Regulatory Transformation?

• Regulatory DNA + Digital Expertise
  We understand both the content and context of digital compliance.
• Technology-Agnostic Approach
  We work with leading platforms (e.g., Veeva, IQVIA, Agatha) and tailor solutions to your environment.
• Business-IT Alignment
  We speak the language of Regulatory, IT, and Quality — ensuring all stakeholders are aligned.
• Strategic and Scalable
  Whether you need a roadmap, a process redesign, or full transformation support, we deliver at the level you need.

Digital Regulatory Operations Services — Delivering Compliance, Efficiency, and Control

As digitalization reshapes the regulatory landscape, pharmaceutical companies need more than strategies — they need execution-ready services that enable structured data compliance, system integration, and high-quality regulatory submissions. At Arithmos, we deliver specialized digital regulatory operations services that support your teams in staying compliant, connected, and audit-ready — while reducing manual effort and improving data consistency across platforms.

Our Digital Regulatory Services

XEVMPD / IDMP / SPOR Compliance Services

Regulators are increasingly requiring structured product data submission and maintenance. Arithmos provides full-service support for:

• XEVMPD data creation, validation, and submission for centrally and nationally authorized products
• IDMP data model alignment in anticipation of upcoming EMA implementation (across substance, product, organization, and referential data)
• SPOR data preparation and synchronization, including Organization and Referential data mapping and validation
• Continuous data quality monitoring and compliance tracking
  Our team ensures that your product data is accurate, complete, and regulator-ready — minimizing risk and future remediation effort.

Registrations, Submissions & Variations Management

From initial marketing authorization to post-approval lifecycle updates, Arithmos provides complete support for managing:

• Global product registrations (initial, renewals, line extensions)
• Regulatory submissions in eCTD, NeeS, and national formats
• Variation handling (Type IA, IB, II) — from planning to dossier updates to health authority correspondence
  We coordinate with your global teams, affiliates, and vendors to ensure timely and compliant execution of regulatory procedures across jurisdictions.

Regulatory Document & Content Management

High-quality documentation is critical to regulatory success. Arithmos supports:

• Authoring, quality control, and version control of regulatory documents (SmPC, PIL, QOS, M2 summaries, etc.)
• Structured content reuse and component-level authoring to improve consistency across documents and submissions
• Metadata tagging and classification to support downstream use (e.g., RIM, IDMP, eCTD publishing)
  We ensure that your documents are submission-ready, audit-ready, and digitally structured, reducing manual rework and improving content lifecycle efficiency.

Regulatory Database Maintenance

Managing regulatory data across regulatory platforms and industry databases is increasingly complex and resource-intensive. Arithmos offers operational services to maintain:

• PLM (Product Lifecycle Management) — keeping records up to date and submission-ready
• ESMP (EU Submissions Management Portal) — maintaining structured product data aligned with IDMP requirements
• ePI (electronic Product Information) — version management and authority coordination
• SPOR — master data entry and ongoing data quality checks (OMS, RMS)
  We act as your extended regulatory operations team, ensuring data quality, system compliance, and operational continuity across your digital platforms.

Why Arithmos for Digital Regulatory Operations?

• Regulatory + Technical Expertise: We combine deep knowledge of regulatory requirements with practical platform experience.
• Execution-Ready Teams: Skilled professionals ready to manage operations across EMA systems and internal platforms.
• End-to-End Service Delivery: From data entry and document authoring to submission and ongoing maintenance.
• Scalable and Global: Supporting EU, US, and other key markets with multilingual and regionally aware teams.

Let Arithmos Run Your Digital Regulatory Operations

Whether you’re implementing IDMP compliance, managing a complex variation portfolio, or maintaining data across regulatory databases, Arithmos provides the people, process, and platform know-how to run your digital operations smoothly and compliantly.

Closing:

In Summary, a modern pharmaceutical company that invests in digital regulatory operations benefits from:

• Faster and more compliant global submissions
• Reduced risk and rework
• Enhanced collaboration and integration
• Preparedness for future regulatory models
• A strategic advantage in a competitive market

Digitalization is not merely an IT upgrade — it is a transformation of how regulatory value is delivered to the business and to patients.

Contact us today to learn how our services can streamline your regulatory workload and support your digital transformation journey.