Are you a pharmaceutical company looking to ensure compliance with FDA regulations for your over-the-counter (OTC) drugs? Look no further! Shanghai Spica Co., Ltd. is here to assist you.
The FDA requires OTC drug labels to include essential information such as active ingredients, drug uses, warnings, and dosage instructions. Our expert team specializes in reviewing and analyzing your label components, language, and instructions to ensure they adhere to the latest FDA regulations and compliance guidelines.
With our comprehensive label review service, you can trust us to provide you with a detailed report that includes the most up-to-date FDA regulatory lists, compliance guidelines, warning letters, import alerts, and other relevant documents. We will meticulously assess your label's content, ensuring that it meets all necessary requirements for safety, efficacy, and consumer understanding.
Why choose our label review service? Here are the key benefits:
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3. Updated Information: Our reports will include the most recent FDA regulatory updates, ensuring that your labels are always in line with the latest requirements.
4. Tailored Solutions: We understand that every product is unique. Our team will provide personalized recommendations and suggestions to improve your label's clarity, accuracy, and overall compliance.
Don't let your OTC drug labels fall short of FDA requirements. Contact us today to take advantage of our professional label review service. Let us help you ensure that your products are safe, effective, and fully compliant with FDA regulations.
上海角宿企業(yè)管理咨詢有限公司專注于FDA510(K),N95認(rèn)證,TGA注冊(cè),歐代注冊(cè),歐洲自由銷售證明,MDR認(rèn)證,ISO13485認(rèn)證,SFDA注冊(cè),FDA注冊(cè)等, 歡迎致電 17802157742
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MDR下技術(shù)文件應(yīng)包含哪些內(nèi)容?
1.客戶基本信息(公司英文名稱、地址英文版、產(chǎn)品名)2.產(chǎn)品說明書3.產(chǎn)品包裝及內(nèi)外標(biāo)簽4.產(chǎn)品描述5.UDI-DIs和SR**.設(shè)計(jì)與制造信息??6.1物料清單???6.2生產(chǎn)流程圖???6.3場(chǎng)地描述??6.4合法生產(chǎn)商信息??6.5歐盟授權(quán)代表信息??6
國(guó)內(nèi)醫(yī)療器械標(biāo)簽應(yīng)如何編寫?
國(guó)內(nèi)醫(yī)療器械標(biāo)簽應(yīng)包含以下內(nèi)容:(一)產(chǎn)品名稱、型號(hào)、規(guī)格;(二)注冊(cè)人或者備案人的名稱、住所、聯(lián)系方式,進(jìn)口醫(yī)療器械還應(yīng)當(dāng)載明代理人的名稱、住所及聯(lián)系方式;(三)醫(yī)療器械注冊(cè)證編號(hào)或者備案憑證編號(hào);(四)生產(chǎn)企業(yè)的名稱、住所、生產(chǎn)地址、聯(lián)系方式及生產(chǎn)許可證編號(hào)或者生產(chǎn)備案憑證編號(hào),委托生產(chǎn)的還應(yīng)當(dāng)標(biāo)注受托企業(yè)的名稱、住所、生產(chǎn)地址、生產(chǎn)許可證編號(hào)或者生產(chǎn)備案憑證編號(hào);(五)生產(chǎn)日期,使用期限或者
自由銷售證書(出口銷售證明書)出具機(jī)構(gòu):自由銷售證書(出口銷售證明書)原則上是**由第三方機(jī)構(gòu)出,第三方機(jī)構(gòu)可以是貿(mào)促會(huì),檢測(cè)部門,協(xié)會(huì)部門,檢測(cè)機(jī)構(gòu)等或者可咨詢產(chǎn)品的上級(jí)主管部門*。例如,英國(guó)自由銷售證,即通過英國(guó)藥監(jiān)局MHRA頒發(fā)給歐盟境內(nèi)的制造商或借助歐盟授權(quán)代表頒發(fā)給國(guó)外制造商的出口銷售證明。英國(guó)自由銷售證書辦理的流程是:1)外國(guó)制造商指定英國(guó)責(zé)任人,并簽署協(xié)議2)委托責(zé)任人為其申請(qǐng)MHR
歐盟將醫(yī)療器械分為四類:I類、IIa類、IIb類和III類,其中III類醫(yī)療器械的風(fēng)險(xiǎn)最高。分類規(guī)則如下:規(guī)則1~4、所有非創(chuàng)傷性器械均屬于I類,除非他們:用于儲(chǔ)存體液(血袋例外)IIa類于II a類或較高類型的有源醫(yī)療器械類IIa類改變體液成分IIa/IIb類一些傷口敷料IIa/IIb類?規(guī)則5、侵入人體孔徑的醫(yī)療器械暫時(shí)使用(牙科壓縮材料、檢查手套)I類短期使用(導(dǎo)管、隱形眼鏡)II
公司名: 上海角宿企業(yè)管理咨詢有限公司
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公司名: 上海角宿企業(yè)管理咨詢有限公司
聯(lián)系人: 楊經(jīng)理
手 機(jī): 17802157742
電 話:
地 址: 上海浦東申港申港大道133號(hào)609
郵 編:
網(wǎng) 址: bys0613.b2b168.com