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Kunanon Sereesawetrat

Consultant, Regulatory Affairs

Biography

Kunanon Sereesawetrat is a consultant in Tilleke & Gibbins’ regulatory affairs team in Bangkok, where he assists clients with matters related to medicinal products, medical devices, and healthcare-related innovations. He has extensive experience in product registration with the Thai Food and Drug Administration and advises clients about Good Manufacturing Practice (GMP) guidelines, Good Storage and Distribution Practices (GSDP), and Good Clinical Practice (GCP) guidelines for clinical trials. He also assists clients with maintaining and amending marketing authorizations throughout the lifecycle of their products, and he advises on current life sciences regulations, especially in relation to pharmaceuticals and medical devices, based on local and overseas regulations (e.g., EMA and USFDA).

Prior to joining Tilleke & Gibbins, Kunanon was a regulatory affairs executive for multiple pharmaceutical companies in Thailand, where he was responsible for supervising GSDP and handled the registration of medicinal products, including generics and biosimilars.

He is also an active member of the Thai Industrial Pharmacist Association (TIPA), the Regulatory Affairs Pharmacy Association of Thailand (RAPAT) and the Pharmaceutical Association of Thailand under Royal Patronage. His frequent participation in regulatory update meetings held by regulatory authorities, RAPAT, and TIPA provides valuable opportunities for Kunanon to convey the concerns and interests of his clients in key industry venues.

Kunanon holds a bachelor’s degree (Doctor of Pharmacy, PharmD) from Mahidol University and a license to practice the pharmacy profession from the Pharmacy Council of Thailand.

Experience

  • Prepared applications and reviewed related documents for product approval licenses for registration and variation of drugs and medical devices in compliance with FDA regulations.
  • Assisted local and international pharmaceutical companies in publishing services (both full ICH eCTD and NeeS) to obtain the document packages used for medicinal products (both chemical and biologics) registration and variation, in compliance with FDA requirements and regulations.
  • Provided comprehensive advice to a contract research organization (CRO) and company that were sponsors upholding clinical trial requirements on their responsibilities and potential penalties for noncompliance in Thailand.
  • Provided advice to a local company on the relevant legal requirements for importation of advanced technology-derived biological products and advanced therapy medicinal products (ATMPs) into Thailand.
  • Advised various local and international pharmaceutical and medical device companies on strategies for obtaining import licenses, manufacturing licenses, product registration, product variation, and other related submissions necessary for complying with the Thai FDA regulatory framework.
  • Advised an international company with different business lines on obtaining a product license and import licenses for connected agricultural technology.
ABOUT Kunanon

Industries

Life Sciences

Practices

Regulatory Affairs

Location

Languages

    Thai

    English

Education

    PharmD, Mahidol University

Insights

December 15, 2023
As part of its membership in Lex Mundi, Tilleke & Gibbins has published an updated edition of its Guide to Doing Business in Thailand for 2023. This guide outlines the key factors for starting and operating a business in the Thai market. Issues covered include: Investment incentives Financial facilities Exchange controls Import and export regulations Structures for doing business Requirements for the Establishment of a Business Operation of the Business Cessation or Termination of the Business Labor legislation, relations, and supply Tax Immigration requirements This publication is part of Lex Mundi’s Country Guides series prepared by member firms in more than 100 jurisdictions worldwide. The guides serve as a useful resource for planning international business strategy and researching new markets. The full Guide to Doing Business in Thailand is available through the button below.
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April 1, 2022
Thailand Legal Basics, a valuable primer for foreign investors, explores all aspects of living and doing business in Thailand. Written by specialists at Tilleke & Gibbins in Bangkok, it is the only comprehensive English-language guide to the Thai legal system with a focus on the concerns of foreign business and investment.
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October 14, 2021
As part of its membership in Lex Mundi, Tilleke & Gibbins has published an updated edition of its Guide to Doing Business in Thailand for 2021. This guide outlines all of the key factors for starting and operating a business in the Thai market. Issues covered include: Investment incentives Financial facilities Exchange controls Import and export regulations Structures for doing business Requirements for the Establishment of a Business Operation of the Business Cessation or Termination of the Business Labor legislation, relations, and supply Tax Immigration requirements This publication is part of Lex Mundi’s Guides to Doing Business series prepared by member firms in more than 100 jurisdictions worldwide. The guides serve as a useful resource when planning an international business strategy or researching a new market.
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May 5, 2017
As part of its membership in Lex Mundi, Tilleke & Gibbins has published an updated edition of its Guide to Doing Business in Thailand for 2019.This guide offers a broad introduction to all of the key factors for starting and operating a business in the Thai market. Issues covered include:
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Awards & Rankings

July 19, 2024
Tilleke & Gibbins has been shortlisted for six awards at the Asialaw Awards 2024. The nominations highlight the firm’s outstanding performance and leadership in Southeast Asia’s legal landscape. The firm has received the following nominations: Regional Corporate/M&A Firm of the Year Cambodia Firm of the Year Laos Firm of the Year Thailand Firm of the Year In addition to the firm nominations, two individuals from Tilleke & Gibbins have been recognized for their exceptional contributions: Prisna Sungwanna – Laos Female Lawyer of the Year Charunun Sathitsuksomboon – Thailand Female Lawyer of the Year The Asialaw Awards celebrate the leading law firms and legal professionals across the region, recognizing excellence in practice and service. The winners will be announced at a ceremony in Kuala Lumpur, Malaysia, on September 26. For more information on the Asialaw Awards 2024 and to browse a full list of the winners, please visit the Asialaw website.
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May 10, 2024
Benchmark Litigation has unveiled its highly anticipated 2024 rankings for the top dispute resolution firms in the Asia-Pacific region, showcasing Tilleke & Gibbins’ continued success in both Thailand and Vietnam. The Benchmark Litigation rankings include two jurisdictions where Tilleke & Gibbins is active—Thailand and Vietnam. Full details of the firm’s rankings are below: Thailand Intellectual Property – Tier 1 Commercial & Transactions – Tier 2 Government & Regulatory – Tier 2 Labor & Employment – Tier 2 Trade & Customs – Tier 2 Vietnam Intellectual Property (Foreign Firms) – Tier 1 Labor & Employment (Foreign Firms) – Recommended (top tier in this category) Commercial & Transactions (Foreign Firms) – Tier 2 Energy & Construction (Foreign Firms) – Tier 2 International Arbitration – Highly Recommended (second-highest tier in this category) In the rankings of individual practitioners, a total of ten Tilleke & Gibbins lawyers were singled out for recognition: Alongkorn Tongmee – Trade & Customs Chusert Supasitthumrong – Labor & Employment Linh Duy Mai Noppramart Thammateeradaycho – Shipping Nuttaphol Arammuang – Intellectual Property Suebsiri Taweepon – Intellectual Property Suruswadee Jaimsuwan Thawat Damsa-ard – Commercial and transactions Tiziana Sucharitkul – Commercial and Transactions, Government and Regulatory K. Loc – Intellectual Property Benchmark Litigation provides coverage of litigation and disputes markets around the world, based on interviews with dispute resolution specialists and clients, as well as analysis of the market’s most important cases and firm developments. To learn more about the rankings and to browse the results, please visit the Benchmark Litigation website.
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April 24, 2024
Tilleke & Gibbins has been honored with accolades in 11 categories of the 2024 Thailand Law Firm Awards from Asia Business Law Journal (ABLJ). The awards recognize the top law firms across a range of practice areas, plus a separate category for the best overall law firms. The firm was recognized as a leader in the following categories: Best Overall Law Firms Aviation Competition & Antitrust Data Compliance & Cybersecurity ESG Fintech Healthcare & Life Sciences Labor & Employment Shipping & Maritime Taxation Technology, Media & Telecoms The awards were determined by ABLJ‘s research team, which evaluates law firms based on their recent work, client feedback, and reputation in the market. ABLJ is a legal publication in Asia that provides in-depth coverage of legal and business developments in the region. Through its research and dissemination of key insights, ABLJ seeks to provide in-house counsel with the necessary information and analysis to implement effective legal solutions. The annual Thailand Law Firm Awards celebrate excellence and innovation in the country’s legal industry. For more information on the 2024 Thailand Law Firm Awards, and to browse of the full list of winners, please see the ABLJ website.
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April 19, 2024
Asian Legal Business has released its 2024 “Employer of Choice” rankings, and Tilleke & Gibbins has once again secured top honors as a premier employer in the legal sector in both Thailand and Vietnam. This marks the 12th consecutive year that the firm has been recognized as Employer of Choice in Thailand and the 10th time in Vietnam. In the article accompanying the list of leading employee-centric firms, Tilleke & Gibbins’ managing partners, Darani Vachanavuttivong and Tiziana Sucharitkul, shared their perspectives on what distinguishes the firm as an appealing and progressive workplace. Darani highlighted the firm’s commitment to fostering a supportive environment that promotes productivity and mental health, emphasizing the significance of transparency and open communication within the organization. Tiziana discussed the firm’s application of cutting-edge technologies like generative AI to enhance legal services and noted the importance of fostering a culture that celebrates diversity and inclusion. The Employer of Choice accolades recognize the most outstanding law firms to work for across the Asia-Pacific region. Rankings are determined through a comprehensive online survey involving law firm professionals at all levels, covering a spectrum of topics including job satisfaction, compensation, work-life balance, career advancement, mentoring, and more. Asian Legal Business is a trusted information source for businesses and professionals, owned by Thomson Reuters. To read more about the 2024 Employer of Choice recognitions, please see the April 2024 edition of Asian Legal Business.
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