The Swissmedic Innovation Office provides regulatory support and advice to start-ups, spin-offs, research groups and incubators that drive innovation of new health products and technologies. It offers a stepwise concept based on your requirements and the developmental stage of your project.

In the pilot phase, which will last until the end of 2024, consulting is focused  on advanced therapeutic medicinal products (ATMPs) as defined in Switzerland (Cell and gene therapies, siRNA, Oligonucleotide products etc.).

Presubmission Meetings

• Very early stage of development
• General (scientific) guidance and regulatory briefing
• Informal exchange on general issues with regard to the medicinal product class

Scientific Advice

• Specific project/product related aspects during the developmental phase of a medicinal product
• Questions about (for example) the quality of active pharmaceutical ingredients and pharmaceutical products, about the planning and organisation of preclinical investigations and clinical trials, or about aspects of pharmacovigilance and the risk management plan.
• Simultaneous advice with participation of other agencies could be considered

Scientific advice or pre-submission meetings are not just offered for authorisation applications but also, for example, for establishment licences for new production facilities or for situations in which re-searchers have to decide on the best study design for their new active substance at an early stage of drug development.

Clarification Meetings

• Presentation of product pipeline
• Information regarding relevant developments in advance of a clinical trial application or marketing authorisation