REGULIFY is a licensed partner in Korea that provides regulatory affairs services for pharmaceutical products. They offer tailored RA services to help professionals develop the most effective regulatory strategy for product development, registration, and commercialization. REGULIFY's team of professionals can assist clients in navigating complex regulatory requirements and ensuring compliance. Additionally, their services include regulatory operations, publishing, and life-cycle management. As a full-service regulatory affairs provider, REGULIFY can support Pharmaceutical and Biologic companies throughout the entire product development process, from registration to commercialization. By partnering with REGULIFY, clients can have confidence in their expertise and commitment to delivering high-quality services.

REGULIFY is a reputable regulatory affairs partner in Korea with a local team of regulatory experts who are familiar with the local regulations and requirements. They provide a clear regulatory pathway for product development and registration in different markets and offer a list of necessary documentation, timelines, and costs. REGULIFY is committed to ensuring compliance with all regulatory requirements and providing tailored solutions to meet clients' business objectives. By partnering with REGULIFY, clients can benefit from their local expertise and regulatory knowledge, making it easier to navigate the complex regulatory landscape.

Medical writing is a crucial aspect of scientific communication, and it involves creating various documents like regulatory reports, research-related reports, educational materials, and promotional literature. REGULIFY offers professional medical writing services delivered by experts who present complex scientific information in a clear and concise manner that is tailored to different audiences like health authorities, patients, physicians, or regulators. The team of medical doctors and professionals at REGULIFY possesses in-depth knowledge of medical concepts and terminology and is familiar with relevant guidelines regarding the structure and contents of specific documents. They use exceptional writing skills to provide high-quality medical writing services that meet your specific requirements.

REGULIFY offers comprehensive services for the registration of orphan drugs in Korea, including regulatory affairs, gap analysis, consultation meetings with health authorities, and preparation and submission of applications for orphan drug designation (ODD) in multiple countries. With extensive experience in defining appropriate regulatory and clinical development strategies, our team has successfully obtained ODD approvals for many drugs in Korea in record time. We also provide annual reports and help clients make the best use of incentives for orphan drugs. Partner with REGULIFY for tailored solutions to meet your business needs and ensure compliance with all regulatory requirements.

REGULIFY provides clinical expertise to conduct clinical studies in compliance with ICH guidelines and other regulatory requirements. The team offers services like protocol development, site identification and qualification, clinical and medical monitoring, statistical analysis, electronic data capture, and more. The strategies help minimize the risks in patient recruitment, while providing access to appropriate sites and patients. Other services include Central Lab Oversight and Coordination, Site Quality Assurance Audits, and Integrated Final Clinical Study Report to ensure the success of your clinical trials.