We can help you develop a global regulatory strategy for your product by determining the classification, regulatory pathway as well as streamlining the process by mitigating associated risks.

We can support you to write / compile / review technical dossiers for worldwide regulatory submissions and communicate with notified body as well as competent authority on your behalf.

We assist you to comply with the post market requirements from Post-Market Surveillance report upto Vigilance support (Reportable Incidents to authorities, FSCA, FSN)

We provide assistance with the implementation of regulatory procedures in your company or train your team