Stevanato Group quality commitment
At Stevanato Group, quality is not a function, it is the foundation of everything we do.
Our solutions play a critical role in protecting the integrity of therapies that patients rely on every day. Behind every product is a patient, a family, and a moment that matters. This responsibility drives us to uphold the highest standards of safety, reliability, and regulatory compliance across our global operations.
We view quality as an integrated, end-to-end commitment spanning the entire lifecycle of our customers’ products, from early development through commercialization and beyond. By partnering closely with our customers, we ensure that quality is designed from the beginning, built into every process, and sustained through continuous monitoring and improvement.
Our approach is grounded in three core principles:
- Patient safety — ensuring that every decision we make ultimately protects and benefits the end user
- Operational excellence — delivering “right first time” performance through robust processes, technology, and data-driven oversight
- Accountability and transparency — fostering a culture where every individual owns quality and where we engage openly with customers, regulators, and partners
Quality at Stevanato Group is enabled by a strong, globally harmonized Quality Management System aligned with international standards and Good Manufacturing Practices. This framework ensures consistency, scalability, and compliance across all our sites, while continuously evolving to meet the changing expectations of the healthcare landscape.
We are committed not only to meeting requirements, but to anticipating them by listening to the voice of our customers, monitoring industry trends, and innovating proactively to support the future of healthcare.
Ultimately, quality is how we build trust with our customers, with regulators, and most importantly, with patients worldwide.
Stevanato Group’s Quality Policy
Stevanato Group aims to partner and accompany its customers through the life cycle of their products from concept development to commercialization and post-sales support.
The Group is committed to delivering high-quality products, advanced technologies, and services that fulfill and anticipate its customers’ needs and ensure end-user safety.
Stevanato Group focuses on its customers, monitoring and measuring the performance of the organization to guarantee the reliability of the supply chain and ensure the quality of its products and services.
The organization is committed to complying with all applicable standards, customer needs, and regulatory requirements.
Everyone in Stevanato Group, from senior management to each individual employee, is accountable and strives to ensure the continuous improvement and the effectiveness of Stevanato Group’s Quality Management System.
Stevanato Group encourages its employees to heed the voice of the customer, industry trends, and report back so it can anticipate future needs and deliver excellence in terms of quality and regulatory standards for its products and services.
― Franco Stevanato, Chairman & Chief Executive Officer
Regulatory Support
In a complex and evolving regulatory environment, the Stevanato Group regulatory affairs team is dedicated to helping customers with regulatory inquiries and supporting them with their regulatory submissions to secure their projects and optimize time-to-market.
Our team is composed of regulatory affairs professionals, experienced in primary packaging components, container closure systems, and drug delivery devices, with a global presence in the U.S., EU, and APAC.
We have extensive experience in performing license maintenance activities on a worldwide basis. The function supports the license holder in meeting regulatory obligations for new market approvals, product reclassification, and marketed product line extensions, while minimizing future compliance risks.
Furthermore, where applicable, we support customers in the preparation and management of technical and regulatory documentation to support submissions, including Notified Body Opinions, Drug Master Files (DMFs), and equivalent documentation. This helps ensure consistency, completeness, and alignment with applicable regulatory requirements.
Regulatory Affairs maintains multiple Master Files and provides our customers with Letters of Authorization (LOA) that grant health authorities secure, direct access to our Master Files in parallel with their submissions.
Feedback on a request for an LOA is provided within 5 business days. Unless otherwise agreed, the LOA will be issued within 20 business days.
The Regulatory Department can provide expertise, consultancy, and data concerning our products' most critical topics. These include:
- Technical documentation review and support in preparation
- Extractables
- Biological Evaluation
- Sterile barrier effect
- Packaging validation for finished sterile goods
- Stability studies according to the most updated version of applicable Harmonized and Recognized Standards.
Stevanato Group maintains GMP compliance evidence and validated sterilization records for sterile primary packaging manufacturing operations, supporting customers' foreign building GMP compliance activities under Health Canada GUI‑0080.
ISO Certifications
All Stevanato Group sites have established quality systems compliant with industry standards and applicable certifications for the QMS.