Regulatory Support
Timely regulatory affairs: Generate efficiency work sequence to improve regulatory performance

OLIC provide drug regulatory affairs (RA) solutions in wide range of products e.g. medicinal, medical device, veterinary product, cosmetic and food. Our solutions are custom-built with high quality to each clients’ project. Our team is trained in variety of issue, overcome regulatory challenges, deeply understand regulatory concept and expertise in strategic planning.

 

We provide support throughout the process from primary assessment, prepare the whole common technical dossier or electronic common technical dossier and submission to approval. Along with preparing statements for regulatory authority, regulatory consultancy service and post-marketing services that are required. We keep up with regulation

Our Regulatory Services are included
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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 Check

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AW Preparation & Review

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Dossier Submission

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Follow Up and Provide State

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Major variation / Minor variation

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Renewal

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Law & 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
  • MFDS
  • RUSSIAN FBI SIMP
  • AEMPS
  • 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 provide more information and answers to your questions.
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