Regulatory Services

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6 Key Challenges in South Korea’s Pharma Regulations & Solutions

  South Korea is a rapidly growing pharmaceutical market with a well-established regulatory framework governed by the Ministry of Food and Drug Safety (MFDS). However, foreign pharmaceutical companies often face complex MFDS regulations when entering the market. Understanding these challenges and developing a strong regulatory submission strategy is essential for successful market entry. Here are six key regulatory challenges and strategies to overcome them: 1. Registration of Overseas Manufacturing Facilities  Foreign manufacturers must register their facilities with the MFDS before import declaration. This process involves strict compliance with MFDS regulations, detailed documentation, and adherence to Good Manufacturing Practices (GMP). How to Overcome It: Ensure early registration through the MFDS online platform. Maintain comprehensive documentation to meet MFDS regulatory submission requirements. Collaborate with local regulatory experts to streamline the submission pro...
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Regulatory services in Japan

With a comprehensive Regulatory framework, Japan stands a competitive market for foreign medicinal and medical devices manufacturers while investing in the region. Not only the stringent regulations inclusive of language barriers, but also the expensive Regulatory procedural challenges demand a special attention from manufacturers, who are willing to enter the region. To get the market access, manufacturers must comply with Japan’s Pharmaceutical and Medical Device Act (PMD Act), which is regulated by the Pharmaceutical and Medical Devices Agency (PMDA). Freyr Provides  Regulatory services in Japan Leveraging our cutting-edge knowledge on the Japan’s Regulatory Affairs, Freyr, as a specialized Regulatory partner, can assist foreign manufacturers to streamline their device approval process cost-effectively and in a timely manner. Freyr’s Regulatory services in Japan span across: Medical devices Cosmetics Biotech
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MAA Post Approval Submissions, Activities, Drug, Pharmaceuticals

Freyr support MAA Post Approval Submission s of Generic Medicinal products for EU member states to maintain the Regulatory compliance as per HAs by filing Variations and helps in streamlining the changes in formulation & Post-approval activities. After a marketing authorization application (MAA) is granted approval in European Union (EU), in view of commercialization of a product (minimize costs, time or other reasons), the manufacturer may consider making necessary changes. Such changes must be notified to the Health Authorities (HAs) by proposing a Post-approval change submission. As per the guidance, any changes proposed to the registered content in MAA shall be informed to HAs by filing Variations. Based on the impact of changes on quality of the medicinal product, they are categorised as: Major Changes: Have substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product / drug substance as these factors may relat...
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