介绍
Gahyun Kim's practice focuses on healthcare-related matters, including pharmaceuticals, medical Devices, and health and medical treatment.
Related Practices
履历
2022-至今
Bae, Kim & Lee LLC
主要业务案例
Advised and represented multiple domestic pharmaceutical companies in litigation for declaration of non-existence of debt and damages lawsuit involving detection of impurities (NDMA)
Advised and represented domestic pharmaceutical companies in administrative litigation and suspension of execution related to the revocation of manufacturing and sales (import) licenses for pharmaceutical products
Advised on authorizations and permits for pharmaceuticals, medical devices, foods, and cosmetics
Advised on labeling and advertising of pharmaceuticals, medical devices, foods, and cosmetics
Advised on response to investigations and sanctions by government agencies such as the Ministry of Food and Drug Safety
Civil, criminal, and administrative litigation in the healthcare sector
Advised and represented domestic pharmaceutical companies in administrative and criminal litigation regarding violations of the Pharmaceutical Affairs Act involving indirect export of botulinum toxin products
Advised and represented multiple domestic pharmaceutical companies in litigation for declaration of non-existence of debt and damages lawsuit involving detection of impurities (NDMA)
Advised and represented domestic pharmaceutical companies in administrative litigation and suspension of execution related to the revocation of manufacturing and sales (import) licenses for pharmaceutical products
Advised and represented in administrative appeals, suspension of execution, and administrative litigation related to sanctions for violations of labeling and advertising regulations applicable to foods, health functional foods, and imported foods
Advised and represented the represenetative of a domestic food company in criminal litigation involving violation of the Act on Special Measures for the Control of Public Health Crimes (manufacturing illegal foods)
Advised and represented in administrative litigation related to cancellation of pharmacy business registration
Advised and represented in administrative appeals and litigation related to rejection of business registration
Advised and represented in administrative litigation related to reduction of medical care benefits
Advice on the healthcare sector and regulatory response
Advised on authorizations and permits for pharmaceuticals, medical devices, foods, and cosmetics
Advised on labeling and advertising of pharmaceuticals, medical devices, foods, and cosmetics
Advised on distribution order of pharmaceuticals and medical devices
Advised on response to investigations and sanctions by government agencies such as the Ministry of Food and Drug Safety
Advised on response to amendments to notifications issued by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety
Advised on import food regulations
Advised on wholesale business permits for pharmaceuticals (including response to public health centers and investigative agencies)
Advised on data protection systems for pharmaceuticals
Advised on compliance with the Anti-Corruption Act and Pharmaceutical Affairs Act for global and domestic medical device and pharmaceutical companies and execution of internal investigations
Advised on drug pricing systems and related projects (e.g., response to amendments to foreign drug pricing reference standards, volume-based drug price adjustment system, reassessment projects based on international price comparisons, price negotiations, etc.)
Advised on development of radiopharmaceuticals
Advised on management services organizations (MSOs)
Advised on issues related to violations of the Medical Service Act and other regulations by medical institutions (including response to the Health Insurance Review & Assessment Service, the National Health Insurance Service, and the Ministry of Health and Welfare, etc.)
Advised on establishment and operation of social welfare facilities, etc.
Advised on animal blood products
学历
2022
Ewha Womans University Law School (J.D.)
2019
Seoul National University (B.A.)
资格
2022
Korea
