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.

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.

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.