We provide a comprehensive one-stop service from development strategy planning to post-market quality change management and safety management!
Our company leverages its strength in providing a consistent one-stop service, from strategic planning for development to post-marketing quality change management and safety management. We have established a system that allows clients to easily consult with us on all aspects of regulatory affairs, and we will make effective proposals tailored to our clients' needs. We will advance a wide range of business support, including assistance with obtaining manufacturing and sales licenses, post-marketing quality change management, and safety management, while walking alongside our clients. 【Reasons to Choose Us】 ■ Comprehensive backup for all three roles ■ Strategic proposals tailored to clients' needs ■ Reasonable costs and improved operational efficiency ■ Global standard quality *For more details, please download the PDF or feel free to contact us.
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【Flow of Transactions】 1. Inquiry 2. Hearing 3. Proposal and Quotation 4. Contract and Order 5. Provision of Services 6. Confirmation and Delivery 7. Payment *For more details, please download the PDF or feel free to contact us.
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Q's Consulting Co., Ltd. offers a wide range of services centered around consulting. Leveraging our strength in providing a consistent one-stop service from strategic planning for development to post-marketing quality change management and safety management, we support problem-solving and business efficiency improvements. ◇ Main Support Services We provide consulting services such as support for regulatory strategy planning, work analysis for streamlining safety management operations, and proposals for business improvements, as well as assistance in obtaining and renewing manufacturing and sales licenses. We also undertake safety management operations for pharmaceuticals and medical devices, including the collection and review of safety management information (such as adverse effects) and the creation of action plans. Additionally, we support change management operations related to manufacturing methods, specifications, and testing methods, maintenance of approval documents, minor change notifications primarily related to CMC, and assistance with some change application approvals, as part of our quality change management services. Please feel free to consult with us if you have any requests.