Scandinavian Regulatory Services

Strategical Consulting

From early product development, our team of consultants can guide you to a regulatory pathway that will lead to a smooth and timely regulatory approval. Formal strategic development plans can be drawn up and implemented. Furthermore, we can provide global regulatory intelligence. We can guide you through the development of your product and prepare you for Scientific Advice with the appropriate regulators, and help you to select the appropriate route.

Depending on the character of your product, Scientific Advice can be sought from national authorities and/or the European Medicines Agency (EMA). If your product has the potential to be classified as an Orphan Product, or you plan to develop a Paediatric Indication, special procedures apply, and we can handle your contacts with the EMA.