Doctor signing documents

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

You can benefit from our broad technical registration expertise and in-depth knowledge of local regulations.

We are your 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
  • Product classification assessment

End-to-end product registration

Handling the entire product registration with:

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

Reliable regulatory partner along the entire product life cycle

Ensuring products follow the regulations throughout their life cycle with:

  • Marketing Authorization (MA) holding, maintenance and transfer
  • Variations (minor and major)
  • Renewal
  • Advertising compliance check
  • Pharmacovigilance
Doctors discussing

Our experts have driven sales for both large and small pharmaceutical companies in Asia.

Doctor typing on a laptop

What is happening in the Asian pharmaceutical markets that you should be aware of?