| Global Market Strategy: “Understanding and Preparing for Regulatory Guidelines is Essential”
Sooyoung Kwak joined JNPMEDI in September as the right person to strengthen the company’s global clinical competitiveness. Drawing on her experience working with regulatory agencies and companies, she aims to assist domestic medical device companies with regulatory approvals.
We are in an era where consulting for regulatory approvals has become essential. As the saying goes, “Know yourself and know your enemy, and you will win every battle.” To successfully enter the global market, it is crucial to understand the unique characteristics of each target country and formulate strategies accordingly. JNPMEDI, which offers consulting services for medical device regulatory approvals to domestic companies, recently brought on board Sooyoung Kwak as a Senior Project Leader to bolster its global clinical competitiveness. Senior Project Leader Kwak brings valuable experience from both regulatory agencies and the corporate world.
In a recent interview at JNPMEDI’s office in Seodaemun-gu, Seoul, Senior Project Leader Kwak emphasized, "To enhance global clinical competitiveness, we must target markets with country-specific strategies. It’s essential to understand and prepare according to regulatory guidelines, while also having a clear purpose for the device’s intended use."
Senior Project Leader Kwak is recognized as an expert with experience at both regulatory agencies and corporations. She previously worked at the Ministry of Food and Drug Safety (MFDS) and the Korea Disease Control and Prevention Agency (KDCA), handling clinical reviews, clinical trial approvals, and statistical evaluations for manufacturing and import permits. During her time at Lunit, she contributed to obtaining U.S. Food and Drug Administration (FDA) approval for Lunit's Insight product line (CXR Triage, MMG, DBT). Now, at JNPMEDI, she leverages her experience to assist domestic companies with regulatory consulting.
Reflecting on her decision to join JNPMEDI, Senior Project Leader Kwak said, “I have experience reviewing submissions at regulatory agencies and preparing clinical trial data for medical devices at Lunit, including securing FDA approval. I thought this background would be beneficial at JNPMEDI, a company specializing in FDA consulting. Additionally, since there are few companies with dedicated in-house clinical statistics teams, I felt I could contribute significantly to the industry by providing approval consulting.”
To help domestic companies navigate the FDA approval process, Senior Project Leader Kwak advised, "The safety and effectiveness standards required by regulatory agencies like the FDA are clearly defined. Companies must understand and prepare for the review procedures and documentation requirements. Defining the device's intended use clearly from the beginning will make the approval process more efficient.”
Sooyoung Kwak, Senior Project Leader of JNPMEDI is having an interview with Etoday
Sooyoung Kwak, Senior Project Leader of JNPMEDI, emphasized the need for tailored strategies based on the unique circumstances of each country to enhance clinical competitiveness, not only in the U.S. but also in the global market. She explained, “Regulations and healthcare environments differ in the U.S., Europe, the Middle East, and Southeast Asia, so preparation for approvals should be customized accordingly. My role is to understand the needs of the companies and narrow the gap with regulatory agencies.”
JNPMEDI, which started as a clinical trial data analysis platform company, has expanded its scope into consulting services since earlier this year. To support this expansion, the company has been recruiting talents across various fields, including medical devices, clinical statistical analysis, and clinical services. Senior Project Leader Kwak stated, “As JNPMEDI expands its business model into consulting, I believe that bringing in experienced experts who align with the company's goals and direction, while creating synergy and a positive cycle, is a key factor in strengthening our competitiveness.”
For Senior Project Leader Kwak, now in her first month at JNPMEDI, her goal is to help medical device companies successfully enter the markets they are targeting by securing regulatory approvals through JNPMEDI’s consulting services.
She added, “While technology and products may be strong, without clinical statistics personnel, companies can struggle with regulatory approvals. In such cases, I hope to help companies efficiently enter the market through our consulting services.” She also highlighted, “With my experience at both regulatory agencies and corporations, I believe I can bridge the gap between the two sides. I hope to contribute effectively to JNPMEDI, leveraging this experience.”
✔ Original Article Available At: https://www.etoday.co.kr/news/view/2406244
| Global Market Strategy: “Understanding and Preparing for Regulatory Guidelines is Essential”
Sooyoung Kwak joined JNPMEDI in September as the right person to strengthen the company’s global clinical competitiveness. Drawing on her experience working with regulatory agencies and companies, she aims to assist domestic medical device companies with regulatory approvals.
We are in an era where consulting for regulatory approvals has become essential. As the saying goes, “Know yourself and know your enemy, and you will win every battle.” To successfully enter the global market, it is crucial to understand the unique characteristics of each target country and formulate strategies accordingly. JNPMEDI, which offers consulting services for medical device regulatory approvals to domestic companies, recently brought on board Sooyoung Kwak as a Senior Project Leader to bolster its global clinical competitiveness. Senior Project Leader Kwak brings valuable experience from both regulatory agencies and the corporate world.
In a recent interview at JNPMEDI’s office in Seodaemun-gu, Seoul, Senior Project Leader Kwak emphasized, "To enhance global clinical competitiveness, we must target markets with country-specific strategies. It’s essential to understand and prepare according to regulatory guidelines, while also having a clear purpose for the device’s intended use."
Senior Project Leader Kwak is recognized as an expert with experience at both regulatory agencies and corporations. She previously worked at the Ministry of Food and Drug Safety (MFDS) and the Korea Disease Control and Prevention Agency (KDCA), handling clinical reviews, clinical trial approvals, and statistical evaluations for manufacturing and import permits. During her time at Lunit, she contributed to obtaining U.S. Food and Drug Administration (FDA) approval for Lunit's Insight product line (CXR Triage, MMG, DBT). Now, at JNPMEDI, she leverages her experience to assist domestic companies with regulatory consulting.
Reflecting on her decision to join JNPMEDI, Senior Project Leader Kwak said, “I have experience reviewing submissions at regulatory agencies and preparing clinical trial data for medical devices at Lunit, including securing FDA approval. I thought this background would be beneficial at JNPMEDI, a company specializing in FDA consulting. Additionally, since there are few companies with dedicated in-house clinical statistics teams, I felt I could contribute significantly to the industry by providing approval consulting.”
To help domestic companies navigate the FDA approval process, Senior Project Leader Kwak advised, "The safety and effectiveness standards required by regulatory agencies like the FDA are clearly defined. Companies must understand and prepare for the review procedures and documentation requirements. Defining the device's intended use clearly from the beginning will make the approval process more efficient.”
Sooyoung Kwak, Senior Project Leader of JNPMEDI is having an interview with Etoday
Sooyoung Kwak, Senior Project Leader of JNPMEDI, emphasized the need for tailored strategies based on the unique circumstances of each country to enhance clinical competitiveness, not only in the U.S. but also in the global market. She explained, “Regulations and healthcare environments differ in the U.S., Europe, the Middle East, and Southeast Asia, so preparation for approvals should be customized accordingly. My role is to understand the needs of the companies and narrow the gap with regulatory agencies.”
JNPMEDI, which started as a clinical trial data analysis platform company, has expanded its scope into consulting services since earlier this year. To support this expansion, the company has been recruiting talents across various fields, including medical devices, clinical statistical analysis, and clinical services. Senior Project Leader Kwak stated, “As JNPMEDI expands its business model into consulting, I believe that bringing in experienced experts who align with the company's goals and direction, while creating synergy and a positive cycle, is a key factor in strengthening our competitiveness.”
For Senior Project Leader Kwak, now in her first month at JNPMEDI, her goal is to help medical device companies successfully enter the markets they are targeting by securing regulatory approvals through JNPMEDI’s consulting services.
She added, “While technology and products may be strong, without clinical statistics personnel, companies can struggle with regulatory approvals. In such cases, I hope to help companies efficiently enter the market through our consulting services.” She also highlighted, “With my experience at both regulatory agencies and corporations, I believe I can bridge the gap between the two sides. I hope to contribute effectively to JNPMEDI, leveraging this experience.”
✔ Original Article Available At: https://www.etoday.co.kr/news/view/2406244