Pharma Companion App on smartphone for medication adherence

Pharma Companion Apps for Rx, OTC & Orphan Drugs

With the mHealth Suite, we develop therapy- and indication-specific Pharma Companion Apps

For Pharma Partners

Pharma Companion Apps for Rx, OTC & Orphan Drugs

With the mHealth Suite, we develop therapy- and indication-specific Pharma Companion Apps.
Companion Apps as a Bridge Between Therapy, Patients, and Real-World Evidence

Companion Apps as a Bridge Between Therapy, Patients & Real-World Evidence

Creating proximity where others can't reach.

Rare diseases require targeted communication, complex care management, and high-quality patient support. This is exactly where digital Companion Apps make a difference: they guide patients individually through therapy pathways, facilitate education, and connect healthcare professionals with patients.

At the same time, they enable Real-World Data collection – GDPR- and MDR-compliant. Your solution for pre-marketing in compliance with HWG (German Pharmaceutical Advertising Act) – scalable, certified, ready to deploy.

Smartphones with Medication Tracking

Your solution for pre-marketing in compliance with HWG – scalable, certified, ready to deploy.

Rx – Digital Market Launch with a Head Start

Companion Apps as CE-certified medical devices open up legally compliant communication channels to patients and physicians – where traditional marketing falls short. They strengthen brand loyalty, improve patient care, and extend the product lifecycle. Especially during the pre-marketing phase, they strategically activate medical professionals and maximize launch impact.
Smartphones with Barcode Scanner for OTC

Digital companions that turn one-time purchases into real brand experiences.

OTC – More Purchases. More Loyalty. More Brand.

For over-the-counter medications, it’s not just about efficacy but also about recognizability. Companion Apps create lasting brand experiences through reminders, content, and gamified interaction – for recurring touchpoints, loyal customers, and a differentiating brand identity.

We know the market's hurdles. And we have the right platform to overcome them.

Your Challenges?

Rx Challenges

Rx

  • HWG (German Pharmaceutical Advertising Act) prevents early product communication
  • MDR and approval obligations block dynamic execution
  • Physicians and patients are often unprepared at launch
OTC Challenges

OTC

  • Little brand loyalty – high interchangeability
  • No dialogue after purchase – no loyalty
  • Low user engagement and no continuous data utilization
Orphan Drugs Challenges

Orphan Drugs

  • Very small target groups – hard to reach
  • Complex therapy pathways – high information needs
  • Low awareness – minimal market attention

The Smart Pharma Companion App for Your Medication

Our Promise

Whether Rx, OTC, or Orphan Drug – we make your vision digital. With the mHealth Suite, you bring a Pharma Companion App to market that delivers more: Early patient activation, recurring brand engagement, Real-World insights.

CE-certified, HWG-compliant, MDR-ready – faster, more scalable, and more strategically valuable than ever before. For all phases. For all markets. For your growth objectives.

Maximize the Potential of Your Medication with Pharma Companion Apps

How Pharmaceutical Companies Benefit from the mHealth Suite

Fast Time-to-Market

Fast Time-to-Market

We reduce 12–18 months of development to 3 months – CE-certified apps launch in parallel with or ahead of regulatory approval.
Long-Term Regulatory Assurance

Long-Term Regulatory Assurance

Pre-validated components and automated compliance workflows – DiGAV, MDR, and BSI compliant.
Pre-Marketing Innovation

Pre-Marketing Innovation

We enable compliant, direct, indication-specific patient communication – even before Rx approval and in full compliance with advertising regulations. Secure a 6-month market advantage.
mHealth Suite Platform

Certified, Secure, and Compliant App Development

The mHealth Suite

DUX Healthcare is ISO 13485 certified and has deep regulatory expertise – including MDR, BSI TR-03161, and GDPR compliance. Our platform meets the highest standards for security, data protection, and scalability.

Over 80 DTx modules deliver fast, cost-efficient, and highly customizable solutions. Instead of developing every feature from scratch, we combine existing modules tailored to each indication – quality and compliance standards are built in from the start.

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CASE STUDY: My-formoline L112 - Companion

The My-formoline app is your reliable partner on the path to a healthier and more active lifestyle – specifically designed to support the use of formoline L112. As a medical device, the app offers numerous features that guide you step by step toward reaching and maintaining your weight loss goals.

Features include: Weight tracking, weekly overviews, step counter, hydration reminders, intake reminders, and a comprehensive knowledge library.

VIEW IN APP STORE VIEW IN PLAY STORE

FAQ

Getting Started
Is the mHealth Suite a platform I can use myself?
No – the mHealth Suite is our internal manufacturing framework. You receive a finished product on our proven infrastructure – including development, operations, and regulatory assurance. You provide the therapy concept – we handle implementation, certification, and maintenance.
What does the mHealth Suite offer?
A scalable platform for developing CE-certified digital health applications in just three months. 80+ pre-validated DTx modules, automated documentation, and integrated compliance. Predictable costs through a transparent subscription model.
How quickly can I go live?
Approximately 3 months from kick-off to CE marking. A lifestyle MVP in as little as 8 weeks. Pre-validated components reduce development time by up to 80%.
How does the pricing model work?
One-time setup fee + monthly subscription fee. Minimum term of 12 months. Includes hosting, maintenance, compliance services, support, and further development.
Compliance & Certification
Who assumes the role of Legal Manufacturer?
Either you or our certified regulatory partner. Complete MDR-compliant documentation and ISO 13485-compliant processes support both paths.
Does the mHealth Suite cover all regulatory requirements?
Yes. MDR, DiGAV/DiPAV, BSI TR-03161, and BfArM data protection criteria. Additional features such as ePA integration or Health ID available on request.
After Launch
What happens after launch?
Hosting, compliance maintenance, release management, monitoring, and further development – all covered by the subscription fee.
Can I add features later?
Yes. New features, indications, or content – without jeopardizing CE certification.
Scaling & Flexibility
Is scaling possible?
Yes. The modular architecture enables expansion to additional indications. Existing documentation is reused.
Can custom modules be added?
Yes. Tailored add-on modules are seamlessly integrated, validated, and documented. With exclusive usage rights on request.

Contact our experts

Start your Pharma Companion App now.

DUX Healthcare GmbH (ehem. fluidmobile)

Bachstraße 43 76185 Karlsruhe +49 721 754 072 39 contact@dux-healthcare.com