Diseases affecting the respiratory tract often require the topical application of medication. Asthma and chronic obstructive pulmonary disease are among the most prominent examples for such conditions. Inhalers are medical devices used for bringing the drug which may be a powder or solution into the appropriate state while delivering it to the required sites e.g. bronchia or lungs. However, also drugs with a systemic effect may be delivered through the respiratory tract.
Whenever the size of the particles or – in case of solutions – droplets matters e.g. to assure the deposition at a certain site (e.g. upper or lower respiratory tract, sinuses, etc.) the development of the drug substance and the inhalation device must go hand in hand. This raises the likelihood that the final product will be a combination product – the technical term for the FDA-regulated market – or a medicinal product with (non-) integral device component – for the EU market.
anteris medical supports its customers in all aspects related to the medical device part. Years of experience in the field of combination products allow us to diligently plan for the crucial contact points between drug and medical/ integral device component development (e.g. design verification/ validation and regulatory strategy) right from project launch.
anteris medical is proud to support our customer laying out a project plan that best fits the needs of drug and device development while Integrating normative and regulatory requirements of the various target markets.
- Combination Product
- Medicinal Product with (Non-) Integral Device Component
- Design Development Planning
- Design Validation
- Design Verification
- Regulatory Strategy
- Coordination of drug development and medical/ integral device component development
- Aligning time plans of e.g. clinical studies and device development
- Coping with iterative cycles that may occur during development as drug product and device component coevolve
- Bringing together pharma and device language
- Establishing technical documentation under the customers’ or our Quality Management System (ISO 13485 certification may or may not be required)
- Support of the regulatory dossier and regulatory filing