[ PRESS RELEASE] on November 1st, 2024, Eli Lilly Japan K.K. and Global Regulatory Partners G.K. announced that Eli Lilly Japan would transfer to GRP Japan, its marketing authorization for " BAQSIMI? Nasal Powder 3 mg" (hereinafter referred to as" " BAQSIMI?”) in Japan, an emergency treatment of severe hypoglycemia on December 31, 2024. #GRP #Japan #globalregulatorypartners #pharmaceutical
Global Regulatory Partners, Inc.
商务咨询服务
Framingham，Massachusetts 4,859 位关注者
全球监管合作伙伴是一家咨询公司，提供包括事务，临床，质量和安全性在内的全球服务
关于我们
Global Regulatory Partners，Inc是一家全球咨询公司，为北美，拉丁美洲，亚洲和欧洲的生命科学公司提供个性化的法规事务，质量和安全服务。全球监管事务公司的服务包括：?监管战略?IND，IMPD，IB和CTA的准备和提交。 ?准备和分发NDA，ANDA，BLA，MAA。 ?准备和发送快速订单并指定孤儿药。 ?变化，变更，年度报告和呈件的准备。 ?准备和装运IDE，510（K），PMA和CE标记。 ?项目管理。 ?医学写作。 ?审查和批准促销和广告材料?监管运作，电子提交和出版。 ?GMP审核，ISO 13485审核，质量体系和尽职调查。药物警戒和安全性。
- 网站
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https://www.globalregulatorypartners.com
Global Regulatory Partners, Inc.的外部链接
- 所属行业
- 商务咨询服务
- 规模
- 11-50 人
- 总部
- Framingham，Massachusetts
- 类型
- 私人持股
- 创立
- 2010
- 领域
- audits、regulatory affairs、Pharmaceuticals、Clinical、Regulatory intelligence、Regulatory Operations、Medical Devices、Authorized Local Agent、Innovative Products、Orphan Drugs、Distribution和Market Access
地点
Global Regulatory Partners, Inc.员工
动态
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On September 20th, 2024, Global Regulatory Partners Mexico LLC, the designated local representative for Amphastar Inc. and the Baqsimi? Product in Mexico, received The notice of MAT Approval by COFEPRIS.??#Mexico #COFEPRIS #globalregulatorypartners
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PRESS RELEASE: On September 12th,2024 Global Regulatory Partner Inc. through its subsidiary in Mexico submitted to the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the health authority in Mexico, received the approval of the freeze-dried version of smallpox vaccine.??#MEXICO #COFEPRIS #MONKEYPOX #globalregulatorypartners
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PRESS RELEASE: On Thursday, August 1, 2024 the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) approved the Marketing Authorization Transfer of REDEVANT? from Eli Lilly and Company to Kowa Company, Ltd.??#globalregulatorypartners #mexico #COFEPRIS
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The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.
ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.
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The import of products into Brazil is subject to various regulations, with proper labelling being a crucial part of this procedure. These regulations cover the current standards for labelling imported products, outlining the responsibilities of importers and the essential elements that must be included on labels.
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The import of Health products into Brazil is subject to various regulations, with proper labelling being a crucial part of this procedure. https://lnkd.in/e7XNFNYX #brazil #globalregulatorypartners #import #anvisa #market #regulations
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Brazil's Anvisa revises Regulation guidelines RDC 752/2022, and included new cosmetic labeling requirements. #cosmetics #brazil #anvisa #marketaccess #globalregulatorypartners https://lnkd.in/gYF2aW_G
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Brazil's Anvisa updated regulation for medical devices RDC 830/2023, which deals with risk classification, notification, and registration regimes, as well as labelling requirements and instructions for use for in vitro diagnostic medical devices, including their instruments, will be implemented from June 1st,2024. #brazil #anvisa #medicaldevice #ivd #globalregulatorypartners https://lnkd.in/gV4SnYdF
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The future is AI, so how will it be utilized in Medicine? The FDA has released publication on this discussion. #AI #FDA #pharmaceuticalindustry https://lnkd.in/gkJU4Tez