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Greetings from Freyr South Korea

Freyr is a global Regulatory leader providing services and solutions to life sciences companies in their entire Regulatory value chain. With our presence in 120+ countries, we support life sciences companies in their “local to global” journey. At Freyr South Korea, we support companies register their products with the Ministry of Food and Drug Safety (MFDS), Regulatory Strategy, Market Intelligence, In-country representation, and many more. We also offer next-gen Regulatory software solutions covering the complete registration life cycle.

 

Industries We Serve

As part of the international multicentre development programs, global pharmaceutical companies are turning towards South Korea for conducting clinical trials. This hints towards an upcoming surge in Drug Development and Regulatory services in South Korea and an increase in the number of MFDS registrations. To be a part of South Korea’s pharmaceutical market, however, foreign drug developers need to be aware of the stringent registration and Regulatory pathways laid out by the MFDS.

Click here to find out how to successfully register your drug in South Korea.

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South Korea is one of the biggest markets for health care in Asia-Pacific region. The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the Regulatory body regulates the Medical Devices in South Korea. Current regulations formedical device registration in South Korea are covered under the Medical Device Act (MDA) and Act on Invitro Diagnostic Medical Devices. Marketing approval from local Medical Device authority and National Institute of Medical Device Safety Information (NIDS) which functions under the scope of the Ministry of Food and Drug Safety (MFDS) is mandatory to enter the South Korean Medical Devices market. An additional requirement for foreign device manufacturers is appointing a Korea License Holder (KLH).

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In South Korea, healthy foods are regulated by the Ministry of Health, Labour, and Welfare (MHLW) under the Food Sanitation Law. South Korea is a major food importer, with a food self-sufficiency rate of about 40%. Therefore, foods are imported from various countries. To ensure the safety of the imported foods, the MHLW monitors and inspects them at the quarantine stations located at international airports and seaports.

Click here to find out how to successfully register your food product in South Korea.

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In South Korea, cosmetic products are regulated by the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Law (PMDL), formerly known as Pharmaceutical Affairs Law. The MHLW focuses on reviewing the applications of quasi-drugs and cosmetic registrations in South Korea (foreign manufacturer, importer) and evaluates their adverse effect reports.

Click here to find out how to successfully register your cosmetic product in South Korea.

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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc. to Post- Approval / Legacy Product Maintenance, Labelling, Artwork Change Management, and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries. Click to know more.

Freyr Digital

Freyr SUBMIT PRO
Freyr SUBMIT PRO, an eCTD Software that Suits All Your Submission Requirements
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Freyr IMPACT
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Freyr PRISM
Freyr SPAR is one such RIM solution that enables life sciences organizations to effectively manage their information, right from tracking product registrations to generating statistical reports
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Freyr PRISM
Create, capture, manage, deliver, monitor, and archive Regulatory data with an end-to-end electronic document management system
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Freyr PRISM
Inquisitive process to track dossiers, submissions, submissions to HA queries, and tasks to meet the challenges of eCTD mandates across the globe
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Freyr PRISM
Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence
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Freyr PRISM
A robust platform to create, validate, store, and submit complex content structures aligning with the SPL’s (FDA) and the SPM’s (HC) standard control vocabularies and validation rules
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