ISO9001:2008 Standart, Quality Management System Certification |
PHDS participates the Chinese Partner of US-China 1000 SME Partnership Program |
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We provide solutions for you. As needs are different, we adopt a multidisciplinary approach, bringing to the table whatever tools are needed to solve your problem.
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Research and Development-----
Smooth the pathway to Chinese market for your compound |
PHDS works closely and actively with the best minds---scientists at universities, medical colleges and research institutes around China who have been engaging in drug research and development for decades and applying their extensive and advanced scientific and technological expertise to each stage of the drug discovery and development process. For your promising compound, you may have limited resources for further development and accomplishment. We here offer you assistances at different stages: |
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Lead discovery and optimization |
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Formulation Design and Optimization |
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Specification Determination and Quality Control |
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Pre-clinical Research |
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Bioequivalence and bioanalysis |
Regulatory Services-----
While fully complying with the regulations, we are flexible enough in our approach to help you obtain the best regulatory result. |
PHDS has multitude resources at different levels to enable a quick response to your need from start-up throughout registration and a speed-up along the project. We know which steps are essential and which activities can be minimized. Our well-established relationship with regulatory Agencies also ensures the most efficient communication channel in between. At PHDS, not only do we care obtaining the approval successfully, but we are very concerned about the time spent on the application. We understand one project may determine the future of an operation, so we do it all with a commitment to bring your product into China faster. We are specialized in: |
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IND and NDA |
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Imported Drug registration |
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Pharmaceutical Excipient Registration (Imported and Domestic) |
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Pharmaceutical Packaging Registration (Imported and Domestic) |
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Rx to OTC Switching Program |
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Health Food Registration (Imported and Domestic) |
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Cosmetics Registration (Imported and Domestic) |
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Food Additives Registration (Imported and Domestic) |
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Novel Food Registration (Imported and Domestic) |
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Disinfectant and Sanitizer Registration (Imported and Domestic) |
Clinical Development-----
Take all the advantages of Clinical Research in China for your therapeutics |
PHDS knows the different regulatory approval procedures amongst FDA, EMEA and SFDA, and understands local laws and cultural aspects that have to be addressed when doing clinical research in China. With strong project management and network of local specialists, PHDS is your portal to clinical research in China: |
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In-house CRFs design and review |
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Investigator selection |
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Site initiation |
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Patient recruitment |
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Monitoring (phase I to IV on both import registration and global trials) |
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SAE reconciliation |
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Data management |
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Data listing and statistical analysis |
Consultation Services-----
Help transform the potential into a winning competitive advantage for your product£º |
PHDS¡¯ relationship with decision makers at government agencies and with sponsors facilitates the understanding of their aims in the medical marketplace, which subsequently allow PHDS to help position a product for optimal commercial returns: |
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Policy consulting, strategies advisory on adaption to ever-changing agency¡¯s guidelines |
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Market size and penetration consulting |
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Economic Strategy and Reimbursement Consulting |
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Post Marketing Surveillance |
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Medical Insurance Consulting |
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Drug Administrative Protection |
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Import Food Label Application |
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