Regulatory services for pharmaceutical companies

DKSH Healthcare Australia Pty. Limited

+61 2 9959 5533
Contact Email
Level 2, 104 Mount Street
North Sydney, NSW 2060
Australia
  • Factsheet Healthcare
    (PDF, 139 KB)
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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

Success stories

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

Our expertise

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

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