Marketing Authorisation applications for medicinal products require both expertise and diligence to ensure that the requirements of the European Medicines Agency (EMA) and the national EU competent authorities are met.
Our experienced regulatory troubleshooters can assist in all regulatory affairs activities such as:
- Regulatory strategies
- Marketing authorisation applications
- Submissions in eCTD format for all procedure types (CP, DCP/MRP and National)
- Life-cycle management