ariu

Compliance services and digital solutions for pharmaceutical companies or organisations seeking higher quality standards.

GxP services

Regulatory expertise and hands-on support across all GxP disciplines

Ensuring compliant documentation, inspection readiness, and risk-based decisions throughout the product lifecycle.

Explore GxP Services

IT solutions

Turnkey IT solutions to structure, access, and leverage your data

Including workflow automation, advanced analytics, ETL migrations, and AI-powered search systems.

Explore IT solutions

Targeted GxP Support

Targeted GxP support when it matters most!
From operational backlogs and resource gaps to new initiatives.

Quality Assurance

Assistance with GMP quality assurance activities

  • Documentation & Training: Document and record control and improvement, training management
  • Batch & Product Review: Batch record review, product quality reviews
  • Change, Deviation & CAPA Management: Change control, deviation and CAPA management, root cause analysis, risk assesment
  • Quality Risk Management: Risk assessment, control and review
  • Supplier & Contractor Qualification: Evaluation and monitoring of external partners
  • Compliance & Self-inspection: Self-inspections and audit preparation
  • Validation & Qualification: Facilities, equipment, processes, and systems
  • Complaint Handling: Handing and investigation of product complaints
Quality Control

Ensuring product and material compliance through comprehensive GMP quality control activities.

  • Documentation: Product and material specification creation, test report review, verification of specifications against transport documentations, review of critical in-process parameters
  • Sampling: Coordination of sample collection, sample transport and sample analysis
  • Material/Product Testing: Verification of analysis results against specifications, preparation of Certificates of Analysis (CoA) and Certificates of Conformity (CoC)
  • Stability programmes: Planning, coordination and reporting of product stability studies
  • OOX results: Investigation and evaluation of unexpected or out-of-specification results, coordination with production and contract laboratories, and management of reference sample testing
Quality Management System

Creation, revision and improvment of quality processes

  • Establishment and extension of pharmaceutical Quality Management Systems, from company foundation to enhanced GxP processes, documenting key operations to preserve critical internal knowledge, and creating user-friendly procedures using process management tools such as process diagrams, BPMN, and RACI
Audit

Conduction of audits

  • Supplier and contractor audits
  • Self-inspections
  • Regulatory gap analyses
  • Preparation, support and follow-up of authority inspections
Regulatory Applications

Handling of regulatory applications for the import and wholesale of medicinal products in German-speaking countries.

  • Preparation and submission of applications for the import, manufacturing and wholesale of medicinal products, fully compliant with national and European legal and regulatory requirements

Need GxP support for your operations?

Get in Touch →

Turnkey IT Solutions

Save time, increase efficiency, and ensure accessible, high-quality data. Enabling your team to make smarter decisions and focus on what matters most.

Custom Software Development & Deployment

Tailored applications and system landscapes that integrate seamlessly into your existing environment and scale with your business

  • Custom enterprise applications (desktop, web, mobile) aligned with your workflows
  • Microsoft Office-based solutions using VSTO, C#, VB.NET, VBA, COM and Office JS API
  • Domain-specific tools (e.g., inventory, logistics, operational tracking systems)
  • Full-stack implementations including backend services, databases, and reporting layers
  • End-to-end deployments including SharePoint environments and integrated business platforms
  • Strong focus on real-world usability and maintainability, integration into existing enterprise ecosystems and structured project ownership and communication
Data & Process Automation

Eliminate manual work by automating data flows and business processes across systems.

  • Workflow automation using Power Platform, PowerShell, and Microsoft Graph API
  • Design of automated ETL pipelines across heterogeneous data sources
  • Data transformation, validation, and migration (PostgreSQL, MSSQL, APIs, Excel, flat files)
  • Event-driven and scheduled process automation
  • Automated reporting and process orchestration
  • Handling of complex, multi-source data environments
  • Continuous data ingestion from external platforms (e.g., CRM systems via APIs)
On-Prem AI-Powered Search

Secure, on-premise AI search solutions for organisations that require full data control.

  • Design and implementation using OpenSearch / Elasticsearch architectures
  • AI-enhanced retrieval using ML models and Sentence Transformers for semantic search
  • Vectorisation and indexing of structured and unstructured enterprise data
  • Secure, self-hosted solutions for sensitive or regulated environments
  • Integration into existing enterprise platforms (CRM, SharePoint)
Database Design & Sync

Stable, scalable architectures built for real operations, not just theory.

  • Scalable relational database architectures (MSSQL, PostgreSQL)
  • Synchronisation mechanisms between distributed and central systems
  • Offline-capable data management with reliable sync and conflict handling
  • Continuous data integration from external systems (e.g., HubSpot API)
Regulatory & Clinical Data Management

Systems that meet strict regulatory requirements while remaining efficient.

  • Development of GxP-compliant applications and platforms
  • SharePoint-based solutions for eCTD and document workflows
  • Migration and structuring of regulatory data
  • Implementation of compliant approval and submission tracking systems
Consulting & Solution Design

Every solution starts with a clear understanding of your requirements and constraints.

  • Technology and architecture consulting
  • Design of tailored, future-proof IT solutions
  • Translation of business and regulatory requirements into technical systems
  • Hands-on guidance from concept to implementation

Let's build solutions that actually work in practice.

Discuss your requirements

Our Focus Industries

Delivering expert GxP consultancy and tailored IT solutions for the pharmaceutical and technology-focused industries, and organisations seeking higher quality standards.

Pharmaceutical Industry

We support manufacturers, importers, and distributors of medicinal products and pharmaceutical active substances, as well as start-ups in the pharmaceutical sector, providing GxP consultancy, compliance guidance, and hands-on operational support tailored to their specific needs.

Our Expertise
  • Quality Assurance
  • Quality Control
  • Quality Management System
  • Regulatory Compliance
  • Regulatory Applications
  • Audit
Typical Challenges
  • Managing operational backlogs
  • Supporting teams during resource shortages
  • Implementing new equipment, processes, and systems
  • Launching new GxP business activities
  • Overseeing outsourced responsibilities and third-party activities
  • Outdated processes no longer meeting compliance standards
Our Solutions
  • Hands-on operational support for QA/QC activities
  • Management and GxP-compliant documentation of qualification and validation projects
  • Planning, execution, and implementation of new GxP business activities
  • Preparation and submission of regulatory applications for wholesale or manufacturing/importer authorisations
  • Regulatory gap analysis
  • Process optimisation
  • Supplier / contractor audits
  • Self-inspections
  • Periodic reviews of the compliance and efficiency level of outsourced processes

Organisations seeking higher process standards or systematic knowledge retention

We help organisations make their business processes less dependent on individual employee knowledge, transform naturally evolved workflows into streamlined and efficient structures, and prepare for quality certifications such as ISO 9001. Our approach ensures that processes are clear, repeatable, and sustainable, providing a strong foundation for consistent performance and continuous improvement.

Our Expertise
  • Process mapping and optimisation
  • ISO 9001-compliant quality management and documentation
  • Development of clear workflows, SOPs, and work instructions
  • Knowledge retention strategies and organisational process standardisation
  • Facilitation of process management workshops and trainings
Typical Challenges
  • Reliance on undocumented or informal processes
  • Inefficient or inconsistent workflows
  • Knowledge loss due to staff turnover or siloed expertise
  • Difficulty meeting quality standards or preparing for ISO 9001 certification
  • Lack of structured, easy-to-use process documentation
Our Solutions
  • Conducting customsed process management workshops to map customer activities, individual responsibilities, process inputs and outputs, and identify current process limitations
  • Providing ready-to-use process documentation structures and templates based on ISO 9001, Business Process Model and Notation (BPMN), and Responsibility Assignment Matrix (RACI)
  • Creating clear, easy-to-read process descriptions and work instructions
  • Developing, implementing, and maintaining customer-specific processes

Technology-driven and Digitally Developing Industries

We support highly regulated and technology-driven organisations across a wide range of sectors—including pharmaceutical companies, banks, transportation providers, cultural institutions, or family-owned businesses. We help these organisations implement customsed IT solutions, enabling them to structure, access, and efficiently leverage complex data environments while maintaining compliance and operational reliability.

Our Expertise
  • Custom software development and deployment (desktop, web, and mobile applications)
  • Data automation, ETL processes, and system integration
  • AI-powered search and indexing solutions
  • Workflow digitalisation and process automation (PowerAutomate, Office integration, custom scripts)
  • Database design, management, and synchronisation solutions (SharePoint, relational)
  • IT project management, customer consulting, and solution optimisation
  • Turnkey IT services for regulated and technology-driven industries
Typical Challenges
  • Managing complex data across multiple systems and formats
  • Integrating legacy systems with new digital solutions
  • Automating workflows without disrupting operations
  • Ensuring compliance and data integrity in highly regulated environments
  • Maintaining operational efficiency despite distributed teams or offline work requirements
  • Balancing customsation and scalability in IT solutions
  • Supporting knowledge retention and process standardisation in technology-driven organisations
Our Solutions
  • Developing and deploying custom software solutions, from barcode systems and Office add-ins to web portals and database applications.
  • Automating data transformation, migration, and integration across diverse formats, APIs, and legacy systems.
  • Implementing AI-powered search pipelines and indexes to structure and efficiently access large data environments.
  • Digitalising processes and automating workflows using tools such as PowerAutomate, custom scripts, and Office integration.
  • Designing and maintaining relational databases, SharePoint environments, and synchronisation solutions that work offline and sync with central systems.
  • Managing projects end-to-end and advising customers on optimal solution implementation to ensure reliable, compliant operations.
  • Providing turnkey IT services, including software deployment, operational support, and continuous product improvement.

What drives us

Our mission is to be a trusted and dedicated partner when organisations face operational backlogs, resource gaps, or the challenges of launching new initiatives. We step in where support is needed most, helping our clients move forward, optimise their operations, and unlock the potential of automated processes.

We are passionate about working at the intersection of human interaction and technical solutions. Understanding real operational challenges and turning them into practical, effective solutions is what drives us every day.

At the same time, we believe that strong economic partnerships create stronger societies. By fostering closer collaboration and exchange between Denmark and Germany, we aim to contribute to a more connected, innovative, and resilient European economy.

Why choose us

We believe strong partnerships are built on trust, quality, and shared commitment. That is why our work is guided by accuracy, reliability, and the ambition to deliver solutions our clients can truly depend on.

At the heart of our work is open and transparent communication. We believe that the best solutions emerge through honest dialogue, where ideas can be shared freely and challenges can be addressed directly.

We also bring a deep understanding of neurodivergence and diverse ways of perception and communication. The strategic potential of neurodivergent team members is naturally recognised and valued throughout our project work.

Management

Founded in January 2026, the company is led by two German-trained engineers: Rebekka Migotti a graduate in Bioprocess Engineering (Dipl.-Ing.) and Molecular Biotechnology (M.Sc.) and Bernard Ypi a graduate in Information Technology (Dipl.-Inf.). Together, they bring complementary expertise that bridges regulated industries and advanced technical development.

Rebekka Migotti contributes over 17 years of professional experience in the regulated Life Science Industry, while Bernard Ypi brings 19 years of experience in software development across both highly regulated and less regulated sectors. This combined background enables the company to approach operational, technical, and regulatory challenges with a balanced and practical perspective.

GxP Services

Rebekka Migotti

Management
Senior Consultant GxP

IT Solutions

Bernard Ypi

Management
Senior Consultant IT

Get in touch

Tell us about your project or challenge. We'll get back to you promptly.

Please note: do not include confidential data in this message. Email is not end-to-end encrypted. We will arrange a secure channel if needed.

Contact details

ariu ApS
Store Grundet Allé 62
7100 Vejle
Denmark


CVR-nummer: 46206215

E-mail: contact@ariu.dk

Privacy Policy

How ariu ApS handles personal data when you visit this website or contact us.