Regulatory Support
Timely regulatory affairs: We create efficient work sequences that improve our regulatory performance.

OLIC renders services regarding drug regulatory affairs (RA) for a wide range of products, e.g. medicine, medical devices, veterinary products, cosmetics and food. Our solutions are custom-built for each client's project, with the highest of quality in mind. Our team is trained to handle a variety of issues, enabling us to meet strict regulations, deeply understand administrative concepts and provide expertise in strategic planning.

 

We provide end-to-end support, starting from the primary assessment, by preparing the common technical dossier or electronic common technical dossier and submitting it for approval. Alongside this, we also prepare statements for regulatory authorities, provide regulatory consultancy and post-marketing services as needed, and keep up-to-date on regulation requirements.

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

Standard Guaranteed: Audited and Certified by Thai and International Regulatory Authorities
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  • Thai FDA (Thailand)
  • US FDA (USA)
  • TGA (Australia)
  • PMDA (Japan)
  • HSA (Singapore)
  • MFDS (South Korea)
  • RUSSIAN FBI SIMP
  • AEMPS (Spain)
  • TFDA (Taiwan)
  • The Certification Center of the Russian Federation
  • The Ministry of Health of the Republic of Belarus
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  • Thai FDA (THAILAND)
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  • Thai FDA (THAILAND)
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  • Thai FDA (THAILAND)
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  • Thai FDA (THAILAND)
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We are pleased to respond to any queries.
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