Regulatory Affairs is the part of drug delivery device development that rarely makes headlines. Yet it ensures promising concepts don’t remain sketches but develop into trusted solutions that meet the highest standards of safety and performance. If innovation is the visible face of device delivery development, regulatory is the compass that keeps it on course. In this blog, we will highlight how regulatory strategy enables ideas to become solutions, supports development through the product lifecycle, and helps ensure that patients worldwide obtain safe and timely access.
Pick up an Ypsomed injection pen or autoinjector and the first things you notice are likely the technology, design, or ease of use. These are the tangible outcomes of Ypsomed’s purpose: making self-care simpler and easier. What is less apparent, but equally essential, is the framework that allows such innovations to become reality. Every new idea must navigate a complex landscape of global regulatory requirements before it can safely reach patients. As such, Regulatory Affairs plays an indispensable role in enabling and supporting innovation.
Ypsomed’s core values and their regulatory relevance
In today’s drug delivery environment, pace and complexity are increasing. The growth of innovative biologics, fast-emerging biosimilars, and rapid penetration of GLP-1 agonists into new indications are just a few examples of how therapy areas, molecules, and patient needs are all evolving.
There is a rising demand for devices that enable outpatient and, in particular, home care. This is partly driven by more engaged patients who expect user-friendly, sometimes connected solutions and a seamless experience with their medication. Simultaneously, regulatory priorities are evolving in step with geopolitical shifts, creating a growing trend toward mandatory localization, more rigorous documentation, and enhanced supply chain visibility across different markets.
In this rapidly evolving environment, Ypsomed’s four strategic pillars serve as guiding principles: a commitment to innovation, standardized yet highly adaptable device platforms, operational excellence, and a deep sense of responsibility. Over the past decades, these values have enabled Ypsomed to establish a mature and proactive approach to regulatory partnership. Rather than simply reacting to new health authority requirements or waiting for the new guidelines to emerge, Ypsomed integrates regulatory expertise as one of several guiding factors throughout development: from innovation to early platform design and through the product lifecycle. This philosophy ensures that innovation is consistently aligned with both regulatory expectations and the evolving needs of patients and pharma partners.
Innovation often starts with a new idea. At Ypsomed, we consider regulatory feasibility early on, alongside user needs and technical design, asking “Can this idea survive the scrutiny of global regulators?”
Platforms supported by regulatory insight
Our platform portfolio – ranging from injection pens to autoinjectors and patch injectors – embodies both technical innovation and regulatory strength, enabling pharma partners to advance new therapies with greater speed and reduced risk.
To stay ahead in a rapidly evolving healthcare environment, Ypsomed invests dedicated resources in regulatory intelligence. This “regulatory radar” enables us to continuously monitor global frameworks, anticipate upcoming changes, and assess their impact on our product portfolio.
To remain aligned with evolving regulatory expectations, we follow a structured, cross-functional process focused on the following practices:
- Proactive engagement – International regulatory trends are continuously monitored, with contributions made to public consultations on draft laws and standards when opportunities arise.
- Cross-industry insights – Beyond medical devices, regulations in related sectors such as pharmaceuticals and chemicals are observed to identify relevant best practices.
- Early requirement analysis – Our teams provide timely insights into new and emerging regulations, ensuring that potential impacts are considered early in product development.
- Continuous adaptation of processes – Our internal procedures are regularly updated to reflect the latest guidelines and regulatory requirements.
By doing so, we ensure our solutions remain compliant with the expectations of health authorities worldwide.
A key strength of Ypsomed’s strategy is the active participation of subject matter experts in international standardization committees and industry associations. This involvement allows us not only to contribute our expertise – such as in the enhancement of the ISO 11608 series for needle-based injection systems – but also to anticipate emerging priorities like user-centric design and sustainability well before they become formal requirements.
For instance, when health authorities began placing greater emphasis on human factors data, Ypsomed responded proactively. Our Regulatory Affairs and Usability Engineering teams co-developed study protocols that directly addressed both FDA and EMA expectations.
This ability to adapt our platforms in real time demonstrates how regulatory intelligence supports compliance while fostering innovation and market readiness.
Innovation behind technology: platforms that evolve
At Ypsomed, innovation is not just about developing new devices or technologies. It is defined by how drug delivery solutions integrate with evolving therapies, regulatory frameworks, and the reality of real-world applications.
The shift from hospital-led to home-use self-injection illustrates this perfectly. Patients now expect devices that are simple, easy to use, reliable, and increasingly connected – a demand that is reshaping both technical and regulatory pathways.
Ypsomed’s innovation strategy is closely tied to its standardized, configurable platform technologies for injection pens, autoinjectors, and patch injectors. Each new project builds on a foundation of proven expertise, transferring learnings and regulatory insights from previous projects. This platform approach ensures that when therapeutic requirements change, such as higher-viscosity or larger-volume injectables, devices can be adapted without unnecessary compliance or development risk. Platform modularity, supported by regulatory insight, is engineered from the outset with flexibility in mind, making subsequent adaptation and scaling far more straightforward.
The power of platform modularity
Ypsomed’s modular platform approach further accelerates development. As platform components are already characterized and validated in manufacturing, new projects can focus on therapy-specific adaptations rather than re-proving fundamentals.
This combination of proven platforms and robust technical documentation enables Regulatory Affairs, together with the project team and quality colleagues, to support or manage multiple submissions for drug-device combination products and medical devices in parallel. Our platform documentation is maintained as “living regulatory files”, continuously updated with authority feedback and systematic voice-of-customer input.
Overall, Ypsomed’s innovation process combines collaboration, multidisciplinary expertise, and transparency. With regulatory professionals embedded from the earliest concept stage, new developments are de-risked, regulatory strategies are strengthened, and submissions worldwide become more predictable and timely.
From innovation and development to global regulatory readiness
Ypsomed manages the transition from innovation to product development with precision, guided by its certified quality management system and global regulatory frameworks. Aside from Regulatory Affairs embedded across the organization, several functions contribute to a compliant and efficient pathway from concept to market:
- R&D and engineering - align device concepts with regulatory pathways from the earliest stages.
- Human factors & usability - design and conduct formative and summative studies that meet the expectations of regulatory authorities.
- Risk management - define and integrate risk mitigation measures into documentation and processes from the very beginning.
- Manufacturing and supply chain - anticipate requirements for scale-up, localization, and traceability.
- Marketing and communications - align labelling, claims, and global launch strategies.
- Business development - translate regulatory insights into value propositions, partner strategies, and market-entry opportunities.
Throughout the development process, comprehensive documentation is prepared to ensure that all safety and performance requirements are consistently fulfilled. These records provide clear traceability to supporting test data and risk analyses, while also taking into account regional regulatory expectations.
Anticipating authority expectations
With decades of experience across drug-device combination products and medical devices, Ypsomed applies deep regulatory expertise to anticipate authority expectations, identify trends, and resolve contradictions before they impact partner projects. In this way, Ypsomed ensures that development is not only innovative and efficient, but also submission-ready and highly standardized — enabling timely approvals and reliable market access.
Lifecycle confidence through regulatory continuity
Regulatory responsibilities do not end with approval; they extend throughout the entire product lifecycle. Ypsomed’s lifecycle management is driven by robust and agile change-control processes, rigorous updates and surveillance programs, and a commitment to continuous improvement. By taking responsibility for ongoing file maintenance, implementing technical updates in line with evolving requirements, and managing interactions with health authorities, Ypsomed reduces the regulatory workload for its partners and helps ensure smooth, compliant market continuity.
One of Ypsomed’s strengths is the ability to coordinate multi-regional launches - parallel or sequenced - in the US, EU, China, India, Japan, and other markets. Local regulatory teams, complemented by manufacturing and supply chain hubs (such as the company’s strategic presence in China), ensure region-specific requirements are met and local market expectations addressed.
To further strengthen this global footprint, Ypsomed is also preparing for a physical presence in the US. This step carries strategic importance by:
- placing us closer to customers,
- enabling faster response to market expectations,
- and mitigating the impact of regional factors such as pricing pressures and tax frameworks.
Together with our European and Asian sites, a US hub will complete Ypsomed’s global network, ensuring agile, compliant, and cost-efficient access to all major healthcare markets.
Embedded evolving requirements
Ypsomed seamlessly embeds changes in regulations and requirements into its platform portfolio—from revisions of technical standards to growing sustainability demands. In parallel, a continuous stream of global submissions is supported by an ongoing and structured dialogue with health authorities, enabling the company to remain aligned with current expectations and to anticipate forthcoming regulatory developments.
Managing end-of-life responsibility
The end of a product’s lifecycle is not just discontinuation. Regulatory compliance and partner obligations must remain aligned until final withdrawal. Ypsomed’s Regulatory Affairs ensure that documentation, labeling, and authority requirements are maintained, providing predictability and transparency. In this way, Ypsomed’s regulatory involvement spans the entire journey of a product—from innovation and development, through global submissions and market access, to end-of-life—ensuring consistent regulatory excellence at every stage.
What sets Ypsomed apart
Ypsomed’s strengths in regulatory expertise stem not from a single process or capability, but from a unique combination of enduring factors:
- Deep collaboration with pharma partners.
- High submission volumes support, giving nuanced insight into how authority trends are enforced in practice.
- Timely implementation of new requirements.
- Organizational mindset of agility, continuous improvement and learning
This readiness – built on core values of innovation, platform flexibility, operational rigor, and a genuine sense of responsibility – allows Ypsomed to anticipate the needs of both regulatory authorities and partners, providing a foundation for long-term trust and value.
Turning complexity into opportunity
In a world where drug delivery technology, regulatory expectations, and patient needs are all in continuous motion, the true measure of success is not simply compliance. It requires anticipation, adaptation, and leadership. For Ypsomed, this means embedding regulatory excellence at every stage: from the very first brainstorming of a new idea, through project development, market launch, to end-of-life. With its regulatory compass, Ypsomed turns complexity into opportunity. With decades of expertise, trusted services, and a platform-based approach, we steer through complexity to ensure products are market-ready, compliant, and aligned with future trends on the horizon. By embedding regulatory excellence into every stage, Ypsomed supports improved patient outcomes and delivers long-term value for partners.
Authors
Stefanie Stark
Stefanie Stark is Head of Regulatory Affairs for the Product Area Pen and Autoinjectors at Ypsomed AG. Since joining the company in 2021, she has led a team of regulatory professionals responsible for guiding drug–device combination products and medical devices from early innovation through regulatory strategy, global submissions, and life-cycle management in close collaboration with pharmaceutical partners. With more than 16 years of experience in regulatory affairs, she has held senior roles focused on international registrations as well as project and portfolio management. Stefanie holds a Diploma in Business Administration, is a certified medical documentalist and a trained nurse.
Sandra Schaerer-Lickova
Sandra Schaerer-Lickova is Regulatory Affairs Manager at Ypsomed, where she supports strategic regulatory projects for pen injectors and drug–device combination products. She started her regulatory career in the pharmaceutical sector, preparing CTDs and managing medicinal product submissions, before expanding into medical technology. Her expertise spans MDR CE marking, Article 117 assessments, and FDA CFR regulations for medical devices and combination products, alongside registrations in global markets including the US, China, Korea, Brazil, and Russia. With a background in chemistry and bioprocess engineering, she now focuses on lifecycle management, technical documentation, and guiding cross-functional teams to ensure regulatory compliance and successful market access.
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