Drug Development

At Arithmos, our Regulatory Affairs consultants bring deep expertise and a cross-functional perspective to support life sciences companies in defining and executing their regulatory strategy — with the ultimate goal of achieving timely and successful Marketing Authorization.

We guide clients through all strategic considerations, tailoring the approach to the specific product, therapeutic area, and target markets.

Our Support Covers:

1. Product Positioning & Differentiation
   We help define the regulatory narrative by assessing product value, target population, and unmet needs — aligning clinical and regulatory goals to position the product competitively in the eyes of health authorities.
2. Regulatory Landscape Analysis
   Our team maps out the evolving regulatory frameworks and requirements across target geographies, identifying risks and opportunities. This includes analysis of local requirements, precedence cases, regulatory trends, and alignment with agencies’ current focus areas (e.g., expedited pathways, digital innovation).
3. Procedure Selection
   We guide clients in choosing the most appropriate regulatory pathway, whether national, centralized (EMA), decentralized, mutual recognition, or other relevant routes — balancing speed, scope, and regulatory expectations.
4. Legal Basis & Dossier Strategy
   We define the most suitable legal basis for submission (e.g., full dossier, well-established use, hybrid, generic, biosimilar) based on development history and available data, ensuring alignment with product lifecycle and IP strategy.
5. Exclusivity Planning
   We advise on data exclusivity, market protection, and orphan designation opportunities, integrating these into the submission strategy to maximize market advantage and defendability.
6. Digital End Point Strategy (Regulatory Perspective)
   In an era where clinical trials increasingly include digital endpoints (e.g., wearables, remote monitoring), we support clients in aligning these innovations with regulatory expectations. We help define data collection, validation, and justification strategies that are regulator-ready, ensuring acceptance of digital evidence as part of the dossier.

Outcome: A Clear, Confident Path to Approval

Through our strategic consulting, Arithmos empowers clients to:

• Accelerate regulatory approvals by choosing the right path from the start
• Mitigate risk through informed planning and early engagement with regulators
• Maximize asset value with a forward-looking approach to lifecycle and exclusivity
• Integrate innovation into the regulatory journey — including digital endpoints and real-world data

Our regulatory strategy services are grounded in scientific rigor, operational experience, and regulatory intelligence, helping you transform your development plans into approvals — and your innovations into patient access.

Regulatory Services Supporting Your Path to Market Authorization

At Arithmos, we don’t just advise — we deliver regulatory services that span the entire product development lifecycle, ensuring that your strategy is translated into efficient, compliant, and successful execution.

We support life sciences companies with the operational expertise and regulatory knowledge needed to manage complex submissions, interact with authorities, and drive their products toward market access across global jurisdictions.

Our Regulatory Services Include:

Scientific Advice Preparation and Management

Engaging with regulators early is key to de-risking development.
We support clients in:

• Preparing briefing packages and targeted questions
• Managing interactions with authorities (EMA, national agencies)
• Coordinating meeting logistics and documentation
  This helps ensure that your clinical, non-clinical, and regulatory plans are aligned with authority expectations.

Orphan Drug Applications (ODAs)

We manage the end-to-end process for ODA submissions:

• Eligibility assessment and justification
• Drafting of the orphan designation application
• Liaising with EMA or FDA for review and responses
  Our experience ensures a solid submission that leverages orphan incentives and exclusivity.

Clinical Trial Applications (CTAs)

Arithmos supports you through the full CTA lifecycle under both legacy and Clinical Trials Regulation (CTR) frameworks:

• Dossier preparation and QC (Module 1/Trial Master File alignment)
• Regulatory authority and ethics committee submission
• CTIS platform support for EU-based submissions
  We help navigate timelines, local requirements, and portal-based processes to minimize delays and rework.

Paediatric Investigation Plans (PIPs)

For products with paediatric indications, we assist in:

• Developing a compliant and scientifically sound PIP
• Submitting via EMA’s IRIS platform
• Managing authority questions and compliance tracking
  Our team ensures alignment with paediatric regulatory expectations while supporting development continuity.

Marketing Authorization Applications (MAAs)

From strategy to dossier delivery, we manage MAAs across centralized and national procedures:

• Regulatory pathway confirmation and procedural planning
• Dossier authoring and submission (eCTD/NeeS formats)
• Lifecycle support (responses to LoQs, RFI management)
• Integration with RIM and document management platforms
  We ensure that all components of your submission are delivered in a timely, validated, and compliant manner.

Platform Support: CTIS, IRIS, and More

Navigating today’s digital regulatory interfaces is complex.
Arithmos provides hands-on platform support and training for:

• CTIS (Clinical Trials Information System – EU CTR)
• IRIS (EMA platform for scientific procedures and orphan designation)
• eCTD submissions and publishing tools
  We help reduce administrative burdens and optimize submission quality and speed.

Digital Endpoint Support (Regulatory Focus)

As clinical trials evolve, digital endpoints (e.g., data from wearables, ePROs, sensors) are becoming central to evidence generation.
We support clients in:

• Justifying digital endpoints from a regulatory perspective
• Integrating digital evidence into CTD dossiers
• Ensuring data quality, traceability, and acceptability
  This ensures your innovation is regulator-ready and scientifically defensible.

Why Arithmos?

• From Advice to Execution: We go beyond consulting — we deliver.
• Experienced, Multi-disciplinary Teams: Regulatory, scientific, digital.
• Expert Platform Support: Specialized knowledge of regulatory systems.
• Accelerated Path to Approval: Optimized procedures, minimized delays.
• Scalable Across Regions: EU, US, and global regulatory knowledge.

Let Arithmos Be Your Partner in Regulatory Execution

Whether you’re submitting your first CTA or preparing a full MAA, Arithmos delivers comprehensive regulatory services that accelerate approval, reduce risk, and enable smooth navigation of the ever-evolving regulatory environment.

Reach out to us to learn how we can help you manage every step toward successful authorization and lifecycle compliance.