Regulatory Activities
We can support you in EU and local regulatory procedures in Hungary, Slovakia, Romania, Ukraine and Serbia in the whole lifecycle of your product.
- Local regulatory contact point and representation
Our Profile:
- Local regulatory strategy and SOP development
- First approval, renewal documentation
- Withdrawal and sunset clause
- Maintenance of product information (SmPC, PIL, labelling)
- Marketing authorization transfer
- xEVMPD maintenance and submission