Regulatory Affairs Support
One of the world’s leading providers and manufacturers of healthcare solutions today. Every service that it provides incorporates the entirety of our knowledge and skills, the company’s deep understanding of users’ needs, and more than 180 years of extensive expertise.
With its constantly growing portfolio of effective medical care solutions, this company makes a substantial contribution towards protecting and improving people’s health. In total, the product range comprises 5,000 different products, 95 percent of which are manufactured by the company. By offering supplementary services and consulting, this company develops the best solution for patients in close partnership with our customers, making a significant contribution to medical advancements.
About the project
This pharmaceutical company engaged ALTEN to guarantee the support the regulatory team of European regulations and related procedures.
Our ALTEN team has brought regulatory expertise, organisational skills and knowledge of applicable EU regulations to the project.
- Human Medicines
- Control Access Program following RMP update:
- Provide support throughout MA lifecycle:
- Medical devices
- Archive & document management (CE, DC, CED, ISO).
- Notification of MD to NCA.
- Provide support for National tenders.
- Provide support to other departments and clients.
- Review/approval promotional materials.