In an increasingly demanding regulatory environment, the 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.
The team is composed of regulatory affairs professionals, experienced in primary packaging components, container closure systems, and drug delivery devices, with a global presence in EU and APAC.
The Regulatory Affairs team has extensive experience in performing license maintenance activities on a worldwide basis. The function not only fulfills the license holder’s obligations, minimizing future compliance risks but also successfully realizes additional revenue streams for marketed products through line extensions, product reclassification, and new market approvals.
Regulatory team members are responsible for:
- Keeping track of the ever-changing legislation in all regions where a company distributes or wishes to distribute its products.
- Advising on legal and scientific restraints and requirements
- Collecting, collating, and evaluating scientific data.
- Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned
- Giving strategic and technical advice at the highest level in the company, making a significant contribution both commercially and scientifically to the success of a development program and the company as a whole.
- Helping the company avoid problems caused by poorly kept records, inappropriate scientific thinking, or poor presentation of data.
- Additionally, the regulatory affairs department regularly participates in the development of product marketing concepts and product development. It is commonly required to approve the design and labeling before the commercial launch.
RA team supports conformity assessment by providing the required documents for the materials used in our systems. Stevanato Group maintains a range of Drug Master Files with the US FDA and Health Canada. These are constantly monitored and updated. LoA’s are provided upon request.
Providing Regulatory Submissions in Electronic Format in US and CANADA OMPI DMFs have been submitted using the electronic common technical document (eCTD) format.
The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
For further information concerning OMPI DMFs, click here.
Regulatory Regulations, Standards, and Guidelines applicable to containers and devices are numerous, evolving, and complex to apply. New MDR Medical Devices Regulation (EU 2017/745) increases the need for our customers to have a reliable partner, well prepared, and structured with robust product development and manufacturing processes established.
The Regulatory Department can provide expertise, consultancy, and data concerning our products' most critical topics. These include extractables and leachables, biocompatibility, sterile barrier effect, and packaging validation for finished sterile goods, stability studies according to the most updated version of applicable Harmonized and Recognized Standards
REQUEST FOR HEALTH CANADA GMP EVIDENCE
How reported in Health Canada Guidance: "How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)" , when a drug is fabricated, packaged/labelled, or tested outside of Canada, the foreign building where those activities occur must be listed on the Canadian importer's drug establishment licence (DEL). For the foreign building to be listed on the DEL, it must be deemed compliant with GMP requirements (as described in Part C, Division 2 of the FDR).
Stevanato Group has obtained the recommended GMP evidence (inspection by qualified authority) to support an application should be submitted by the importer. The GMP evidence have been obtained for SterilVerona S.r.l and Nuova Ompi S.r.l sterilizators.