Another anteris medical key competence: registration support for Combination Products (biologic/device or drug/device combination)
anteris has a very strong record in rendering registration support for complex Combination Products.
Throughout product planning and realization, strategic regulatory decisions are required to ensure smooth regulatory clearance in all target markets.
For example, if your product is a biosimilar product including a device, it has been shown that preparing a regulatory strategy early on with a general description of your drug product and the device constituent part, as well as the comparability exercises, component selection, clarification processes with health authorities and applicable normative requirements for your anticipated target countries facilitate a structured approach to your development. Such an approach in our experience greatly increases the likelihood of success.
Our goal is to provide you with high quality regulatory documentation ready for submission and to support optimal interactions with regulatory authorities and other key stakeholders to facilitate regulatory approval worldwide.
- Combination Product
- Regulatory support
- Health authority interaction
- Regulatory strategy
- Product labeling documents for drugs and devices
- A key challenge is often the availability of regulatory experts familiar with Combination Products throughout the project. In particular, a lack of regulatory input in the early phases of development can easily lead the program in the wrong direction.
- Preparation of Regulatory strategy and other regulatory key documents
- In-house regulatory trainings
- Health authority meeting support (USA, EU) for drugs and devices
- Ensure competent regulatory support and coordination right from the project start
- Global support for biosimilar combination products (autoinjectors, pens, pre-filled syringes with needle safety device)
- Global support for innovative (active, connected) injection systems