| Comprehensive FDA Expert Solution Launched to Provide Total Consulting for FDA Approval… A Specialized Team Includes U.S. Licensed Experts to Support All Stages from Data Preparation to Regulatory Strategy.
| Aims to Significantly Reduce Time and Cost for Companies by Offering End-to-End Support.
| Plans to Establish Systematic Market Access Strategies Based on an Accurate Understanding of U.S. Regulatory Procedures.
JNPMEDI is establishing a foothold for domestic pharmaceutical and biotech companies to enter the U.S. market.
On the 2nd, JNPMEDI, a medical data platform company led by CEO Kwunho Jeong, announced the launch of its FDA Expert Solution, designed to support South Korean pharmaceutical and biotech companies in their efforts to enter the U.S. market. This new service aims to assist companies in obtaining Investigational New Drug (IND) and New Drug Application (NDA) approvals from the U.S. Food and Drug Administration (FDA).
The FDA Expert Solution provides end-to-end services, including: the △Preparation of clinical and non-clinical data, △Document drafting, △Clinical trial management, and △Regulatory strategy formulation. Through this initiative, JNPMEDI will comprehensively support domestic pharmaceutical and biotech companies in obtaining rapid and efficient FDA approval, successfully entering the U.S. market, and achieving results in the global market.
Not only that, the service is designed to be on-demand, allowing companies to access the necessary expertise and resources without needing to seek out multiple vendors. This integrated approach is expected to result in significant time and cost savings for companies.
The team at FDA Expert Solution includes highly qualified professionals such as Chief Medical Officers (CMOs), pharmacists, doctors, and lawyers, all of whom hold U.S. licenses and possess extensive experience in their respective fields. The service is meticulously planned to ensure a deep understanding of U.S. regulatory procedures, paving the way for future global partnerships and systematic market entry strategies. In addition to the FDA Expert Solution, JNPMEDI offers a range of solutions including the JNPMEDI Partners program, which supports global licensing partnerships and investments, potentially creating new revenue streams.
With the introduction of the FDA Expert Solution, the pace of U.S. market entry for domestic pharmaceutical and biotech companies is expected to accelerate. Historically, differences in regulatory environments and the complexity of FDA approval processes have posed significant challenges for Korean companies, often leading to delays, increased costs, and lost market opportunities. The FDA approval has been a major hurdle due to the stringent and intricate requirements, necessitating specialized knowledge, financial resources, and skilled personnel.
CEO Kwunho Jeong stated, "FDA approval is a critical step for successful entry into the U.S. market and is crucial for the growth of pharmaceutical and biotech companies. The FDA Expert Solution is part of our broader strategy to support domestic companies in their global market ventures. We plan to offer a variety of comprehensive consulting services to back these new challenges."
| Comprehensive FDA Expert Solution Launched to Provide Total Consulting for FDA Approval… A Specialized Team Includes U.S. Licensed Experts to Support All Stages from Data Preparation to Regulatory Strategy.
| Aims to Significantly Reduce Time and Cost for Companies by Offering End-to-End Support.
| Plans to Establish Systematic Market Access Strategies Based on an Accurate Understanding of U.S. Regulatory Procedures.
JNPMEDI is establishing a foothold for domestic pharmaceutical and biotech companies to enter the U.S. market.
On the 2nd, JNPMEDI, a medical data platform company led by CEO Kwunho Jeong, announced the launch of its FDA Expert Solution, designed to support South Korean pharmaceutical and biotech companies in their efforts to enter the U.S. market. This new service aims to assist companies in obtaining Investigational New Drug (IND) and New Drug Application (NDA) approvals from the U.S. Food and Drug Administration (FDA).
The FDA Expert Solution provides end-to-end services, including: the △Preparation of clinical and non-clinical data, △Document drafting, △Clinical trial management, and △Regulatory strategy formulation. Through this initiative, JNPMEDI will comprehensively support domestic pharmaceutical and biotech companies in obtaining rapid and efficient FDA approval, successfully entering the U.S. market, and achieving results in the global market.
Not only that, the service is designed to be on-demand, allowing companies to access the necessary expertise and resources without needing to seek out multiple vendors. This integrated approach is expected to result in significant time and cost savings for companies.
The team at FDA Expert Solution includes highly qualified professionals such as Chief Medical Officers (CMOs), pharmacists, doctors, and lawyers, all of whom hold U.S. licenses and possess extensive experience in their respective fields. The service is meticulously planned to ensure a deep understanding of U.S. regulatory procedures, paving the way for future global partnerships and systematic market entry strategies. In addition to the FDA Expert Solution, JNPMEDI offers a range of solutions including the JNPMEDI Partners program, which supports global licensing partnerships and investments, potentially creating new revenue streams.
With the introduction of the FDA Expert Solution, the pace of U.S. market entry for domestic pharmaceutical and biotech companies is expected to accelerate. Historically, differences in regulatory environments and the complexity of FDA approval processes have posed significant challenges for Korean companies, often leading to delays, increased costs, and lost market opportunities. The FDA approval has been a major hurdle due to the stringent and intricate requirements, necessitating specialized knowledge, financial resources, and skilled personnel.
CEO Kwunho Jeong stated, "FDA approval is a critical step for successful entry into the U.S. market and is crucial for the growth of pharmaceutical and biotech companies. The FDA Expert Solution is part of our broader strategy to support domestic companies in their global market ventures. We plan to offer a variety of comprehensive consulting services to back these new challenges."