Why Choose REGULIFY?

Korean Healthcare Regulatory Consulting Professionals

REGULIFY is a consulting firm that offers end-to-end services for bio companies seeking to enter the Korean market.
We offer in-depth knowledge of the Korean market and regulations, reduce regulatory non-compliance risks, shorten the time to market products, and help clients avoid unnecessary costs and delays.

REGULIFY, specializes in

(1) Obtaining Korean regulatory approval for medical devices and pharmaceuticals,
(2) Conducting clinical trials on behalf of clients, and
(3) Connecting approved products with domestic distribution channels.

Medical Devices

REGULIFY is a company that provides regulatory affairs services for medical device companies. They offer a comprehensive range of services to help clients navigate the complex regulatory requirements in various markets, from concept to registration. Their local teams of experts can provide the appropriate regulatory intelligence, strategy, and pathway for registering medical devices in different markets. They also have local offices and strategic partners in Korea that are licensed by local authorities to act as authorized local agents for medical devices and pharmaceuticals. REGULIFY's tailored regulatory affairs services include the latest regulatory information and recommendations for the most appropriate and effective strategy to address clients' particular needs. They pride themselves on their expertise and commitment to helping their clients achieve their goals in a timely and compliant manner.

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Pharmaceuticals

REGULIFY offers comprehensive regulatory affairs services that enable our clients to register their drug, biologic, or generic products in Korea seamlessly. We specialize in regulatory strategy, regulatory operations and publishing, products' registration, and products' life cycle management.
As your trusted local authorized agent in Korea, REGULIFY can support your company throughout the product's lifecycle, ensuring compliance with local regulations and providing crucial scientific and strategic guidance from product development to commercialization. Our regulatory team is well-versed in local regulations and can provide valuable insights to ensure successful product registration and commercialization in Korea.

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