Doctor signing documents

Our team of 100 regulatory healthcare experts help brand owners overcome regulatory challenges across Asia. We provide end-to-end regulatory services: from initial assessment, dossier preparation and submission to approval and then the entire range of post-marketing services that are required. 

You benefit from our broad technical registration expertise and in-depth knowledge of local regulations. We provide a single regional point of contact for all regulatory matters, as well as commercial and distribution services. 

Regulatory consulting    

Preparing smooth market entry with:

  • Regulatory feasibility assessment
  • Labeling requirement assessment

End-to-end product registration  

Handling the entire product registration through:

  • Dossier preparation
  • Compliance check
  • Product sample submission
  • Dossier submission
  • Registration follow-up and monitoring
  • Regulatory approval

Reliable regulatory partner along the entire product lifecycle   

Ensuring products follow the regulations throughout the lifecycle with:

  • Marketing Authorization (MA) holding, maintenance and transfer
  • Variations (minor and major)
  • Renewal
  • Advertising compliance check
  • Field Corrective Action Requirement for Medical Devices
Doctors discussing

We are proud to have expanded the business of many of the world’s leading medical device and diagnostics companies.

Doctor typing on a laptop

What trends and developments are impacting the Asian medical device and diagnostics sector?