We provide up-to-date, innovative and customized global regulatory solutions.
Our support ranges from regulatory strategy and advice on the development of healthcare products, to hands-on operational support during product registration and post-marketing activities. We support our clients in achieving regulatory compliance, facilitating entry to market, minimizing the risk of failure and reducing development costs. Our regulatory affairs team and local partners have long-standing experience in many therapeutic areas and product classes covering drugs, biologics, medical devices, in vitro diagnostics and combination products.
| Early development phase | Registration phase | Maintenance phase |
|---|---|---|
| Defining regulatory, non-clinical and clinical strategy | Interaction and liaison with Health Authorities and Notified Bodies | Preparation of reimbursement dossiers |
| Scientific advice / HTA meeting | CTD dossier writing | Named patient programs |
| Early access evaluation | Technical dossier for devices & IVDs | Full lifecycle management |
| ODD / PIP / CTA | MAA filing | Variations |
| Classification of products | Answering list of questions | Labeling updates |
| Regulatory training | CE-marking | Setting up supply chain at country level |
| Due diligence | Acting as MAH in Switzerland | Referral procedures |