Q. What is a combination product and how is it regulated?

A. A combination product is a product composed of two or more regulated components — a drug and a device, a biologic and a device, or a drug and a biologic — that are physically, chemically, or otherwise combined into a single entity. In the US they are regulated by the FDA under 21 CFR Part 3, with the primary regulatory centre determined by the product’s primary mode of action.

Q. What types of combination products does Aluris manufacture?

A. To be completed by Aluris — specific formats and assembly types to be confirmed.

Q. How do you manage the regulatory complexity of combination products?

A. To be completed by Aluris — specific regulatory frameworks and submission experience to be confirmed.

Q. What is the difference between a drug-device combination product and a medical device with drug coating?

A. A drug-device combination product is regulated based on its primary mode of action, whereas a device with a drug coating may be classified differently depending on whether the drug component has an independent effect. Our regulatory team can support you in determining the correct classification for your product.

Q. Can Aluris support both the drug and device constituent parts, or do I need separate suppliers?

A. To be completed by Aluris — clarity on whether they manufacture or source device components, and how they coordinate constituent part supply.

Q. How do you handle extractables and leachables testing for combination products?

A. To be completed by Aluris — specific approach to E&L testing and whether this is conducted in-house or through qualified testing partners.

Q. Do you support human factors and usability studies for combination products?

A. To be completed by Aluris — confirmation of whether human factors support is offered or coordinated.

Q. What stage of development can you engage from?

A. To be completed by Aluris — earliest stage of program they can productively engage with.

Q. How does your quality system address both drug cGMP and device QSR requirements simultaneously?

A. To be completed by Aluris — specific QMS structure and dual-compliance approach.

Q. What does the technical transfer process look like for a combination product?

A. Combination product transfers are more complex than standard drug or device transfers because they require simultaneous coordination of drug process, device specifications, assembly processes, interface compatibility, and dual regulatory documentation. Aluris’s approach begins with a comprehensive gap assessment across both constituent parts before any transfer activity begins.

Q. Can you support international regulatory submissions for combination products?

A. To be completed by Aluris — confirmation of markets and submission types supported beyond FDA.