Regulify: Your Trusted Partner for Regulatory Affairs Services in Korea
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.
Customized Services for Successful Product Registration and Commercialization
REGULIFY is a trusted partner that specializes in creating effective regulatory strategies for various products and markets. Their team of experts has the knowledge and experience to help businesses achieve their goals in a timely and efficient manner.
Their customized regulatory strategy takes into account multiple factors such as product information, development status, company objectives, applicable regulatory requirements, operational costs, and potential risk assessment during product development, registration, or commercialization. With tailored solutions, REGULIFY ensures compliance and successful product registration and commercialization.
REGULIFY's Local Experts and Presence in Korea
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.
REGULIFY's Regulatory Affairs Support Team
At REGULIFY, our regulatory affairs support team offers a range of services to assist clients in navigating the health authority consultation process smoothly. Our team provides medical writing services, helps prepare and submit meeting packages to health authorities, prepares questions based on product development status and future plans, provides support during the meeting, and writes the meeting minutes.
Following the consultation meeting, we develop a suitable action plan to help clients achieve their regulatory objectives in an efficient and effective manner. Our experts are dedicated to providing tailored solutions that meet clients' business needs while ensuring compliance with all regulatory requirements. By partnering with REGULIFY's regulatory affairs support team, clients can have confidence in our ability to provide high-quality services and achieve their regulatory goals.
Professional Medical Writing Services by REGULIFY
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.
Comprehensive Product Registration Services by REGULIFY
REGULIFY offers comprehensive services for pharmaceutical and biologic product registration in Korea, providing tailored regulatory support from experienced medical professionals. Our team has a proven track record of preparing, compiling, and submitting dossiers for various therapeutic areas. We can handle IND, NDA, MAA, CTA, DMF submissions, life-cycle management, and annual reports. With our strong local presence and expertise, we ensure compliance with necessary regulations. Our regulatory affairs team will also respond to health authority queries and provide ongoing support until formal application approval. Trust us to provide you with the necessary regulatory support for successful product registration.
REGULIFY's Orphan Drug Registration Services
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.
Drug Master File (DMF) Registration Services by REGULIFY
REGULIFY offers Drug Master File (DMF) registration services that provide confidential information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. Although not mandatory by Korean MFDS, DMFs are submitted to safeguard confidential information related to products. REGULIFY provides expertise in regulatory submission strategy for different types of DMFs, preparation and submission of Drug Master Files, DMF life cycle management including amendments and annual reports, and converting existing DMFs to eCTD format. Trust REGULIFY to handle your DMF registration needs with precision and professionalism.
REGULIFY's Clinical Services for Compliant and Successful Clinical Trials in Korea
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.