Drug/device combination products are increasingly complex in terms of components and regulatory requirements. In the case of parenteral products, compliance has to be achieved with pharmaceutical as well as with medical device regulations. Pharmaceutical and biotech developers at times have to deal with a shortage of resources and experience with the selection and development of adequate injection systems (syringes, vial kits, autoinjectors, inhalers, or patch pumps).
anteris systems offers anteris medical's customers testing of injection systems in combination with the customer's pharmaceutical product, thus components can be selected that offer stability and performance consistent with the customer's expectation, requirements, specifications, and label claims. Services include studies for the selection of injection systems or components, for design verification and design output, trouble-shooting and root-cause analysis, and to satisfy requirements by the regulatory bodies (for example the answering of deficiency questions).
We currently work exclusively with an US-partner using cutting edge technology and methods. The spectrum of methods includes, but is not limited to:
- Container characterization
- Standardized syringe testing
- Drug delivery devices
- Measurement and inspection
- On-site precision machining
By 2019 we plan to offer the same analytical services in Europe allowing for an accelerated turn-around for our European customers.