Partnering with Stevanato Group to manufacture your drug delivery device means streamlining your process and getting on board for a burden-free experience. From the early stages of drug development, we can support biopharma companies in identifying and developing the best container-closure system and drug delivery system, all the way through to commercialization.
Integrating products, technologies and services under a single reference point, Stevanato Group boasts a novel business model as a one-stop-shop. During our 70-year history, we have evolved from a glass processor to an established, all-round supplier to the pharmaceutical industry, enabling our clients to fulfill their mission: delivering safe and effective treatments every day.
Thanks to our integrated approach, we can harmonize all the different development processes – from the definition phase to the production and global supply of your device.
We assign you a dedicated team and a project manager to oversee the course of the project and keep you informed of the status of each phase.
Our project managers have extensive experience in lifecycle management and are familiar with the regulatory environment:
Bringing your ideas to life, resulting in a product requirement document
Definition of the proper glass container and container closure system, when needed; elaboration of device concepts and construction of plastic mock-ups.
Development, optimization and documentation according to Design History File (DHF) and Device Master File (DMF), mechanical testing, shelf-life studies, risk management, usability studies, regulatory verification, design for manufacturing
Optimization of your products with our extensive plastic injection molding capabilities, from manual to fully automated assembly, synergizing glass and plastic expertise where appropriate
Bringing your ideas to life, resulting in a product requirement document
Definition of the proper glass container and container closure system, when needed; elaboration of device concepts and construction of plastic mock-ups.
Development, optimization and documentation according to Design History File (DHF) and Device Master File (DMF), mechanical testing, shelf-life studies, risk management, usability studies, regulatory verification, design for manufacturing
Optimization of your products with our extensive plastic injection molding capabilities, from manual to fully automated assembly, synergizing glass and plastic expertise where appropriate
Glass plays a crucial role in the development of drug delivery devices. By continually perfecting the forming process, we have become a leading producer of high quality, high value, ready-to-use, primary packaging.
EZ-fill® containers are now the reference market standard and are at the core of complex drug delivery systems, whether they are based on customized cartridges, syringes, barrels or micro-vials. They comprise:
Over the years, we have amassed an exceptional amount of information about glass containers and delivery solutions: SG Lab is the repository of this knowledge, which ranges from container closure system integrity to specific testing for drug delivery systems, including analytical characterization of drug-device interaction.
Functionality analysis:
Compatibility testing:
Combination products testing:
Ensuring safe and user-friendly devices is indispensable when bringing any healthcare product to market.
Our knowledge, powered by a wide network of external experts, helps biopharma companies navigate through the current regulatory requirements, assisting them with registration strategies, globally.
We can guide through different regulatory pathway in accordance with EU and FDA regulations. We can also support the registration of combination products by providing information to the Applicant by Drug Master Files DMF type III and EU files. We are also highly qualified to assist the client during all phases of product development, through our experience with GMP, 21 CFR 210/211, 21 CFR 820 and Combination Products 21 CFR Part 4.
In addition to glass components, Stevanato Group has extended its portfolio of injection molded plastics, boosting its in-house expertise in tool design and maintenance. All products are accurately measured and visually inspected to meet the most stringent specifications:
Thanks to our industrialization capabilities, sub- and final assembly modules, and flexible packaging lines, we can develop scalable solutions, such as pen injectors, automatic injectors, inhalers, wearables, and accessories, like vial adapters.
Wearables
Inhalers
Pen injectors
Auto-injectors
Accessories
We can develop drug delivery devices in partnership with our customers, relying on third-party IP or through the development of proprietary IP, contributing to improving your manufacturing readiness and time-to-market.
