anteris supports the development of high quality labeling documents for Combination Products in a very flexible and cost-efficient way
anteris has already supported various companies in the development and successful approval of high-quality biologic Combination Products. The responsibilities included the preparation of regulatory strategies and core labeling documents. During the centralised procedure in the EU support with the health authority interaction has been ensured with the timely response to deficiency letters. Strategic labeling leadership and expertise was provided to enable a fast commercialization of Combination Products. The cooperation with safety and labelling key stakeholders were ensured to facilitate the most efficient knowledge transfer for highly complex biologics and devices.
We are proud to have a successful track of professional labeling support for biologics and devices worldwide.
- EU product information preparation
- Handling of centralised procedures
- Linguistic review process
- IFU (instruction for use) preparation
- End to end labeling process analysis
- Core data sheet
- Review of promotional material
- Artwork preparation
- The secrets of efficient combination product development Download the white paper (PDF)
- In order to make an efficient development process of any Combination Product it is essential to involve a cross-functional team right from the start.
- Prepare high quality core labeling source documents right from the start.
- Provide strategic labeling leadership and expertise for drugs, devices and Combination Products
- Ensure regulatory compliance worldwide
- Provide in-house trainings for drugs, devices and Combination Products
- Drive and support interactions with regulatory authorities and key stakeholders for safety and labeling related issues