[Law Firm Now] Daeryun Law Firm Takes Proactive Legal Measures in Clinical Trial Sector

Expansion of Clinical Trial Market Size
Establishment of Pharmaceutical, Bio, and Healthcare Centers
Formation of Task Forces by Issue... Support for New Medical Technology Assessment

As research and development costs of domestic pharmaceutical and bio companies increase, the clinical trial market is also expanding, and the law firm Dae-ryun (Limited) is drawing attention by taking proactive measures to support related legal disputes.

According to the Korea Clinical Trial White Paper by the National Clinical Trial Support Foundation, the estimated R&D expenditure by pharmaceutical companies that received clinical trial plan approval from the Ministry of Food and Drug Safety over the past three years was approximately 4.0099 trillion KRW last year. This represents about a 47% increase compared to the previous year's expenditure of 2.7237 trillion KRW.

Currently, Dae-ryun provides customized advisory services to minimize legal risks in the pharmaceutical, bio, and medical device clinical trial sectors based on the expertise of its medical and pharmaceutical group. In particular, the firm recently established the "Pharmaceutical, Bio & Healthcare Center" within the group, forming task forces for each issue and developing systematic strategies reflecting industry-specific characteristics, thereby expanding its expertise.

The Pharmaceutical, Bio & Healthcare Center operates a one-stop legal support service for companies such as medical institutions and pharmaceutical companies that require clinical trial consultation. Additionally, it is building close cooperative relationships with government and affiliated organizations and related associations to provide more specialized support.

Specifically, it offers professional services in areas such as ▲support for research and development of pharmaceuticals and medical devices ▲legal consultation related to Institutional Review Board (IRB) review and approval ▲protection of intellectual property rights including patent and trademark applications for clinical trial target products.

Furthermore, Dae-ryun provides document advisory services related to new medical technology assessments. This system, which evaluates the safety and clinical efficacy of new medical technologies, requires dual approval from the Korea Health Industry Development Institute and the Ministry of Food and Drug Safety, making it known to be difficult to pass. Based on the assistance of experienced specialized attorneys, Dae-ryun facilitates smooth approval processes.

The head of the Pharmaceutical, Bio & Healthcare Center is Attorney Seo-hyung Lee, who has extensive experience in clinical trial consultation for various pharmaceuticals and medical devices. Additionally, Attorneys Il-hyung Lee, So-young Yoon, and Yoon-jung Choi, who hold pharmacist qualifications, have joined to resolve legal issues faced by pharmaceutical companies and medical device manufacturers and help clients secure product positions in the market. In particular, Attorney Il-hyung Lee, who has extensive experience in patent and R&D contract work, has a deep understanding of the intellectual property field.

Kim Guk-il, CEO of Law Firm Dae-ryun, stated, "With growing interest in the pharmaceutical and healthcare industries recently, clinical trials are also increasing. Since clinical trials are a core process in the development of pharmaceuticals and medical devices, the importance of legal consultation is very high."

He added, "Based on Dae-ryun’s abundant expertise and experience, we will support our clients to operate their businesses stably and become a reliable partner that assists the growth of the pharmaceutical and bio industries."

This content was produced with the assistance of AI translation services.