{"id":1538,"date":"2018-09-10T12:46:43","date_gmt":"2018-09-10T12:46:43","guid":{"rendered":"http:\/\/law-firm.bold-themes.com\/master-import\/?page_id=7"},"modified":"2025-02-07T22:38:40","modified_gmt":"2025-02-07T22:38:40","slug":"%e4%b8%bb%e9%a1%b5","status":"publish","type":"page","link":"https:\/\/deepfda.com\/us\/","title":{"rendered":"\u4e2d\u6c83\u5fb7\u5eb7\u4e3b\u9875"},"content":{"rendered":"

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Comprehensive One-stop Solution for New Drug Application<\/span>BSL-2 (P2)

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About Us<\/span><\/a><\/div>
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Our Services<\/span><\/span><\/h3><\/header>
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Pharmaceutical R&D<\/span>Exploration in Novel Drug<\/span><\/span><\/h3><\/header><\/div>
Early-stage exploration of drug candidates, with literature and data support, IP strategy optimization, and preclinical feasibility and risk analysis.<\/div>
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Preclinical Research<\/span>Preclinical Pharmaceutical Research<\/span><\/span><\/h3><\/header><\/div>
Adhering to regulatory compliance requirements, we develop rational preclinical pharmaceutical research strategies with a focus on the long-term development of drug candidates, providing specialized analysis and research solutions.<\/div>
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Biosafety<\/span>Biodefense and Infectious Disease Research<\/span><\/span><\/h3><\/header><\/div>
In collaboration with multiple global biosafety laboratories at BSL-2 (P2) and BSL-3 (P3) levels, we provide GLP-compliant pharmacodynamic ABSL-3+ (P3+) animal biosafety experimental services.<\/div>
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Analytical Research<\/span>Bioanalytical Research<\/span><\/span><\/h3><\/header><\/div>
Leveraging data from advanced experimental and analytical equipment to establish analytical methods, enhance drug candidate efficacy, manage drugability risks, and ensure compliance with regulatory submission requirements.<\/div>
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About Us<\/span>Backed by a team of experts with over 30 years of experience, we provide comprehensive support to ensure the successful development of drug candidates.<\/span><\/span><\/h3>
We tailor solutions based on the specific needs of each drug candidate, conducting comprehensive analyses of drugability and regulatory risks.<\/div><\/header>
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From laboratory-based drug discovery and exploration to advancing drug candidates into clinical trials, the process is complex and requires comprehensive, multidisciplinary professional services. Decouvor\u2019s experienced team of experts, including immunologists, pathologists, toxicologists, analytical chemists, cancer biologists, molecular biologists, infectious disease scientists, and biopolymer specialists, collaborates with you to develop precise strategies for new drug development and preclinical research. We aim to efficiently advance drug candidates into clinical trials at the most reasonable cost.<\/p>\n

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Learn More About Decouvor<\/span><\/a><\/div>
Accreditation and Compliance<\/span><\/a><\/div>
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Specialized Fields<\/span>Committed to Providing High-Quality Laboratory Services<\/span><\/span><\/h3><\/header>
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Analytical Projects<\/span><\/span><\/h4><\/header>
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Establish analytical and validation methods for drug candidates and evaluate biomarker strategies.<\/p>\n

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Stringent Quality Standards<\/span><\/span><\/h4><\/header>
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In compliance with regulatory submission requirements, we provide GLP and GMP-compliant technical data.<\/p>\n

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Comprehensive Solutions<\/span><\/span><\/h4><\/header>
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The analytical team leverages technical data to optimize pharmacology and toxicology plans for drug candidates.<\/p>\n

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Advanced Analytical Equipment<\/span><\/span><\/h4><\/header>
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Leveraging advanced technologies such as FFF, HPLC, SEC, and GPC, we provide robust technical analysis support for drug candidates.<\/p>\n

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Learn More<\/span><\/a><\/div>
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One-stop Preclinical Trial Design and Regulatory Compliance Services<\/span><\/span><\/h3><\/header>
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Decouvor provides GLP and non-GLP pharmacodynamic studies, in vivo pharmacokinetic studies, and toxicology studies for small molecules, large molecules, vaccines, therapeutic, and immunotherapy drug candidates. We also facilitate technical meetings with regulatory authorities to ensure timely communication of drug candidate data.<\/p>\n

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Reach Out to Our Expert Team<\/span><\/a><\/div>
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Safety Pharmacology Research<\/a><\/span><\/span><\/h5><\/header><\/div><\/div><\/div><\/div>
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Pharmaceutical Toxicology Research<\/a><\/span><\/span><\/h5><\/header><\/div><\/div><\/div><\/div>
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Pharmacokinetic Studies<\/a><\/span><\/span><\/h5><\/header><\/div><\/div><\/div><\/div>
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Medical Devices<\/span>U.S. FDA Medical Device PMA, De Novo, 510(k), and 513 Submissions<\/span><\/span><\/h3>
In accordance with the current manufacturing conditions of medical device companies and the FDA 510(k) application principles, we offer comprehensive, tailored guidance and solutions.<\/div><\/header>
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U.S. FDA Medical Device 510(k) Data Preparation Services: We guide medical device companies in preparing the necessary technical data for FDA 510(k) submissions and ensure compliance for successful application. Decouvor's expert team actively coordinates with FDA reviewers to facilitate timely and effective data exchanges and Q&A sessions.<\/p>\n

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More Information on Medical Devices<\/span><\/a><\/div>
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U.S. FDA Prior Notice for Product Import<\/span><\/span><\/h2>
We provide compliant U.S. FDA agent services to meet regulatory requirements<\/div><\/header>
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The U.S. FDA requires that prior notice be submitted to the FDA before food shipments enter the United States. We will assist companies in obtaining a confirmation number, which will be used by U.S. customs brokers for clearing the goods<\/p>\n

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FDA application and registration of GCAA, DMF, CVM, CDER<\/span><\/span><\/h3>
Obtaining FDA export documentation and permits<\/div><\/header>
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The essence of FDA application and registration lies in ensuring that export products comply with the regulatory requirements of the target market. GCAA oversees facility registration for food and agricultural products. DMF pertains to the quality documentation of pharmaceutical raw materials. CVM regulates animal drugs and pet food. CDER is responsible for drug evaluation and market authorization. For export enterprises, regulatory compliance is a fundamental prerequisite for accessing international markets, ensuring seamless approval processes and lawful distribution.<\/p>\n

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Contact Us<\/span>Access More Service Information<\/span><\/span><\/h3><\/header>
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