Labels for regulated markets: more than printing expertise required

Five-page multilayer label with integrated security features such as anti-counterfeiting and technologies for regulated pharmaceutical and medical device applications.

Regulatory safety starts with the labelling concept

In regulated markets, labelling must be planned early. Information requirements, usability, language variants, traceability elements, symbols, batch data, serialisation and product-specific constraints all influence the final label design. For packaging development, the challenge is to bring these requirements together in a solution that is technically feasible and robust in daily production. A reliable labelling concept considers not only what must appear on the label, but also how the label is produced, applied, read, handled and documented.

Traceability depends on reliable execution

Traceability is only effective when information remains readable, scannable and connected to the right process steps. Barcodes, variable data, batch information or unique identifiers must be integrated in a way that supports both regulatory needs and operational efficiency. This requires careful coordination of substrate, adhesive, printing technology, finishing, data handling and quality controls. Especially in pharma and medtech applications, consistency is essential. A label must perform on the selected packaging material, under defined storage and handling conditions, and within the customer’s production environment.

Material expertise is critical

The right label material is not an easy choice. It depends on the surface, container type, application process, storage conditions, sterilisation requirements, temperature exposure, chemical resistance and expected product lifecycle. Packaging engineers need solutions that work in practice, not only on paper. Material selection, adhesive behaviour and print durability must therefore be evaluated together. This is where technical feasibility and application know-how become decisive. Especially in today’s volatile supply chain environment, qualified backup materials help ensure supply continuity and reduce production risks.

Another pain point of most companies in this sector is change management. With considering backup material qualification in the evaluation process of a new packaging, brand owner can ensure product availability along the lifecycle of their product. Raw material or supplier changes can trigger qualification activities, making long-term availability an important selection criterion.

Functional multi-layer labels help manage complexity

Regulated products often require more information than a conventional single-layer label can carry. Multi-language content, instructions, warnings, regulatory statements or traceability information can quickly create space and usability challenges. Functional multi-layer labels offer a practical solution. They make it possible to integrate extended information while keeping the outer label clear, structured and usable. This can support packaging efficiency, improve information handling and reduce the need for additional leaflets or secondary elements, depending on the application.

As presented at Pharmapack Paris earlier this year, Helvetikett AG has developed an innovative multi-layer label concept with several integrated functions for both segments, Pharma and Medtech. Beyond the technical features, it’s given for Helvetikett to produce these labels based on ISO GMP:15378 standards.

Pharma Multilayer

• up to 7 pages for clinical trials
• cryo-compatible materials and adhesives
• autoclave resistant

Medical Device Multilayer

• RFID applicable
• serialisation options / VDP
• Gamma irradiation up to 100 kGy

Both label concepts can be combined with security features supported by our ISO 14298 certification, including security inks, taggants, holograms and other anti-counterfeiting solutions to protect customer brands and products. 

A strong labelling partner reduces project risk

Successful regulated labelling is the result of early collaboration. The best outcomes are achieved when packaging development, QA, regulatory affairs and the label manufacturer align before final specifications are locked. Helvetikett combines regulatory understanding, material expertise and stable production processes. With consulting competence, technical feasibility checks and ISO 15378 GMP experience, we support customers in developing labelling solutions for demanding regulated applications. Whether you are developing a new packaging concept, reviewing an existing label or evaluating a functional multi-layer solution, the goal is the same: a label that performs reliably, supports traceability and fits your regulatory environment.

Need to discuss a regulated labelling project?

Our Business Development Pharma & Medtech Manager, Pascal Pfleger will be happy to review your requirements and discuss how a functional multi-layer label could support your application. Looking beyond individual projects, staying informed about regulatory developments and supply chain trends is increasingly important. Book a technical consultation with Pascal Pfleger.

Join us at the Helvetikett XCHANGE Day on 12 November 2026 in Zurich, where industry experts will share insights on supply chain resilience, project management and brand protection in regulated markets.