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Regulatory Support

We provide comprehensive regulatory affairs services for a wide range of products, including pharmaceuticals, medical devices, cosmetics, and food. Our services cover initial assessments, preparation of standard technical documents (CTD or eCTD), and submission for approvals. In addition, we offer regulatory agency communications, advisory services, post-market support, and continuous updates to ensure your product registrations remain compliant with current regulations.

Our Regulatory Affairs Services Include:

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  • Primary Assessment and Analysis

  • Compliance Checks

  • Dossier Submission

  • Follow-Ups and Providing Statements

  • Law and Regulation

Our regulatory services include:

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Primary Assessment and Analysis

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Production

Permission

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Import

Permission

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Compliance

Checks

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AW Preparation and Review

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Dossier

Submission

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Follow-Ups and Providing Statements

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Major Variation/Minor Variation

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Renewal

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Law and

Regulation

Certified Standards: Inspected and approved by Thai and international regulatory authorities.

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THFDA

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Drug
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Cosmetic
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THFDA

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Supplement
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THFDA

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Medical device
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THFDA

For more information,
please contact us

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