Our approach is grounded in three core principles:
About
Quality & Regulatory Support
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.
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: master files & letters of authorization
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.
loa
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.
Dear Customer,
Please fill out one (1) LOA request form for each drug product submission. The requested LOA(s) will be sent to you by e-mail. A LOA request needs to list only one targeted health authority.
The LOA provides authorization to health authorities to review Ompi Master Files in parallel to the Marketing Authorization Holder (MAH) application. Upon receiving your request, Ompi will proceed to provide you with LOA, by e-mail not later than four working days from the day of request, if otherwise not indicated or requested with urgency.
Once LOA is signed, DMF update and LOA will be forwarded to competent Regulatory Authority by 20 business days, if otherwise not requested.
Note: * = Required fields
LOA for U.S. FDA, Health Canada
中国国家药品监督管理局药包材企业授权使用书
Dear Customer / 尊敬的客户，
The requested LOA is only applicable to the submission in China.
本页面申请的授权使用书仅限中国申报使用。
Please fill out a separate LOA request form for each drug product application. The color scan copies of the requested LOA(s) will be sent to you by E-Mail.
请为每一份需要注册申报的制剂填写一份授权使用书申请表。授权使用书彩色扫描件会通过电子邮件寄送。
The LOA provides authorization to the Center for Drug Evaluation (CDE), NMPA to review SG files in parallel with the Marketing Authorization Holder (MAH) application. Upon receiving your request, SG will prepare the LOA.
授权使用书授权药品审评中心（CDE）在审查制剂申请时关联审评 SG 提交的资料。收到您的需求后，SG 将为您准备授权使用书。
Note / 注：
- Chinese is the official language of the LOA.
中文是授权使用书的官方语言。 - Effective 02 July 2020, CDE authorized the use of copies of a Letter of Authorization (LOA) as acceptable for drug filings. Therefore, the original hard copies of the LOA normally will not be mailed.
自 2020 年 07 月 02 日起，CDE 已批准使用药包材授权书复印件进行制剂申报。因此，签署的授权使用书纸质版原件通常不再寄出。 - * = Required fields / 必填项
LOA for NMPA China
gmp
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.
Dear Customer,
To take care of your request in the best way please fill mandatory fields as indicated below. PLEASE NOTE , The evidence request submitted without an application tracking number may lead to the rejection of the application.
Note: * = Required fields
Health Canada GMP Evidence
certifications
ISO Certifications
All Stevanato Group sites have established quality systems compliant with industry standards and applicable certifications for the QMS.
| Label | ISO 15378 | ISO 13485 | ISO 9001 | ISO 45001 | ISO 14001 | ISO 50001 |
|---|---|---|---|---|---|---|
| Nuova Ompi (IT-PD) | Download | Download | Download | Download | Download | Local law |
| Nuova Ompi (IT-LT) | Download | n/a | Download | Download | Download | Local law |
| Nuova Ompi (IT-Cisterna) | Download | Download | Download | Download | Download | Local law |
| Medical Glass | Download | n/a | Download | Download | Download | No |
| Ompi of America (IN-U.S.) | Download | Download | Download | Download | Download | n/a |
| Ompi N. America | Download | n/a | Download | Download | Download | No |
| Ompi of China | Download | n/a | Download | Download | Download | No |
| Ompi do Brasil | Download | n/a | Download | Download | Download | No |
| Balda Medical (DE) | Download | Download | Download | Download | Download | Download |
| Spami | n/a | n/a | Download | n/a | n/a | n/a |
| Stevanato Group Denmark | n/a | n/a | Download | n/a | n/a | n/a |
| EMEA TEC, U.S. TEC | n/a | Download | Download | n/a | n/a | n/a |
Interested in Regulatory support?
Submit your request