Medical Devices

Medical Device Industry: Challenges and Regulatory Affairs

The medical device industry faces increasing challenges due to complex technologies and regulatory changes. At REGULIFY, our local teams of experts provide regulatory intelligence, strategy, and pathways for medical device registration in different markets. We also act as authorized local agents for medical devices and pharmaceuticals in Korea, licensed by local authorities.

Regulatory Affairs (RA) is a critical tool for regulatory professionals in the medical device industry. It enables the development of an appropriate regulatory strategy for successful, efficient, and cost-effective product development, registration, and commercialization. At REGULIFY, we offer tailored RA services, providing the latest regulatory information and our recommendations for the most effective strategy to address clients' specific needs. We are committed to helping our clients achieve their goals in a timely and compliant manner, with expertise and professionalism.

Korean Regulatory Affairs Services by REGULIFY

REGULIFY is a regulatory affairs consulting firm that provides a range of services to medical device companies. Its team of experts helps companies navigate complex regulatory requirements to efficiently register and commercialize their products. The company's services include regulatory strategy development, regulatory operations and publishing, product registration, registration amendments, and consulting meetings with regulatory authorities. REGULIFY's regulatory affairs support team offers expertise in compliance and regulatory requirements to ensure a successful product registration process. The company is committed to providing tailored and effective regulatory solutions to meet the unique needs of its clients.

Regulatory Strategy and Medical Writing Services by REGULIFY

Developing the right regulatory strategy for products in different markets is crucial for successful product development, registration, and commercialization. REGULIFY offers customized regulatory strategies that help meet business objectives and minimize risks. The team gathers information about products, market competition, business goals, and regulatory requirements, and then develops a regulatory strategy that includes necessary documentation, timelines, costs, and action plans.

Medical writing is a crucial aspect of regulatory affairs and can determine the success or failure of new products. Poorly written documents can lead to queries from health authorities and delays in product approval. REGULIFY's team of professional medical professionals and doctors specialize in writing regulatory and clinical documents that meet regulatory requirements. They write documents in Electrical Common Technical Documents (eCTD) and CTD modules, ensuring precise, clear, and well-written documents.

Medical Device Registration in Korea: Challenges and Solutions

REGULIFY's Regulatory Affairs team provides comprehensive regulatory support to medical device companies looking to register and maintain their products in Korea. With a deep understanding of the country's unique regulatory authority and compliance requirements, our team can prepare registration dossiers and provide translation services in line with the latest regulations. Our local teams of experts have established strong relationships with health authorities, ensuring efficient and successful product registration for our clients.

REGULIFY Provides Health Authority Consultation Services for Pharmaceutical and Biologic Products

Consultation meetings with Korean MFDS are highly recommended during the development of new pharmaceutical or biologic products. REGULIFY's regulatory affairs team offers support in all aspects of the consultation process, including medical writing, preparation of meeting packages, support during meetings, and development of meeting minutes and appropriate action plans. They also provide trustworthy and professional regulatory writing and consultation services to assist medical device companies in understanding and managing diverse regulatory requirements. With a local team of experts, they offer customized regulatory strategies to achieve business objectives and minimize risks.

Comprehensive Expert IND Services for Korean IND by REGULIFY

REGULIFY provides Expert IND Services, offering a comprehensive range of services for Korean IND, including protocol development, site identification and qualification, clinical and medical monitoring, DSMB coordination, statistical analysis, electronic trial master file, central lab oversight and coordination, site quality assurance audits, and integrated final clinical study report. Their experienced team helps to address recruitment and retention challenges in IND studies while ensuring compliance with ICH guidelines and other regulatory requirements. They also provide training and support to investigators and site staff to ensure that the study is conducted safely and ethically.