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Regulatory services for OTC & consumer health companies

Kon Hiung Lai

General Manager, Regional Quality Assurance

+60378828723
Contact Email
DKSH Malaysia Sdn Bhd
47301 Petaling Jaya
Malaysia
  • Factsheet Healthcare
    (PDF, 139 KB)
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Our team of 90 regulatory healthcare experts help brand owners overcome regulatory challenges across Asia Pacific and Switzerland. 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
  • Product classification 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
  • Pharmacovigilance

Success stories

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Our experts have driven sales for both large and small OTC and consumer health companies in Asia.

Our expertise

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What is happening in the quickly developing Asian OTC and consumer health markets?

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