YPSOMED AG—SELF CARE SOLUTIONS
Product approval in an environment that is subject to international regulation using 4PEP
The Ypsomed group is leading and independent in the development and production of injection systems for self-administered medication. With 4PEP, Ypsomed relies on the competency of ILC GmbH in the area of Regulatory Affairs Management. As proven diabetes specialists with more than 25 years experience, arisen from the well-known Disetronic, Ypsomed now offers insulin pumps and injections systems as well as pen needles for the treatment of diabetes, growth disorders, infertility and other therapeutic areas. Ypsomed is a renowned leader in innovation and technology and is thus a preferred partner of pharma and biotech companies in the area of self-medication.
Customer Quote
“With 4PEP Regulatory Affairs Management, we control our international approval processes safely and quickly. We were able to always represent our requirements flexibly with the solution from ILC. ILC consultants’ high process competency resulted in a high quality implementation.”
Fernand Portenier, Head of IT, Ypsomed AG
Company
- name: YPSOMED AG
- location: Burgdorf (CH), additional production sites and subsidiaries
- industry: medical technology
- products: injection systems for
- self-medication
- sales: 379 m CHF (2020)
- employees: 1,816 worldwide
- www.ypsomed.com
Initial situation and challenge
- process oriented planning, processing and periodic renewal of the approval
- quality assurance and control at any site
- analysis and optimization of existing processes
- increase of legal safety of existing approvals
Solution
- secure management of all documents relevant to the approval
- dossier management on the basis of checklists
- submission management: overview of the current status of the approval at the
- push of a button time management with reminder function
Customer benefits
- IT-supported, safe approval process
- transparency concerning all approvals at the push of a button
- traceability by third parties
- efficient and structured working method
