We provide extensive support for equipment diagnostics and inspection responses! We offer appropriate assistance to support healthy manufacturing.
Our company has been deeply involved in the construction and operation of pharmaceutical manufacturing facilities for many years. We provide support for equipment diagnostics that comply with GMP and regulations, as well as assistance in preparing for inspections, addressing identified issues, and proposing improvements. We can assist with tasks such as "preliminary equipment diagnostics" and "measures and improvement proposals for identified issues." We can also provide specific advice on how to address detailed points and requests, as well as methods of explanation, so please feel free to consult with us. [Examples of services we can provide] ■ Preliminary equipment diagnostics ■ Advice on methods of explanation (anticipated Q&A) ■ Preliminary responses to potential issues ■ Measures and improvement proposals for identified issues *For more details, please refer to the PDF document or feel free to contact us.
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basic information
Do you have any such issues?" - We have been diligently working on GxP as a company, but it would be reassuring to receive opinions and support from a third-party perspective regarding any points that might be raised during inspections. - We have had very challenging experiences during past inspections, and the management is very interested in measures for the future. - Since we are engaged in contract manufacturing, we want to respond not only to inspections from authorities but also to those from our clients. *For more details, please refer to the PDF document or feel free to contact us.
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Applications/Examples of results
【Examples of Achievements】 ■ Consulting for an aseptic preparation factory in preparation for FDA inspection ■ Response to FDA inspection for a cosmetic raw materials factory *For more details, please refer to the PDF document or feel free to contact us.
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Company information
Our company was founded in September 2012 and specializes in engineering services that include validation and calibration, focusing on consulting, planning, design, and construction related to the establishment and renovation of pharmaceutical manufacturing facilities and research facilities based on GxP. With the motto of "User's Engineering," we prioritize the quality of pharmaceuticals and work closely with our clients involved in pharmaceutical manufacturing. We emphasize practicality and feasibility, collaborating with our clients to visualize and solve the challenges faced by each manufacturing site.