Scandinavian Regulatory Services

Regulatory consulting

We provide comprehensive regulatory services for pharmaceuticals and medical devices. We have experience to guide you through the classification steps in the different interfaces and support your regulatory procedures for market access.

Through our sister company, SDS, starting from the early phases, we can provide strategic advice during product development. Project management can be provided in preparing the necessary documentation for submission.

Once all documentation has been established, SRS will support in handling the day-to-day communication with the authorities during the assessment phase of the procedure.

SRS can also help with the regulatory life-cycle maintenance including variations and renewals, as well as with relevant post-approval activities. We can act as your representative.