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. In addition to equipment diagnostics that comply with GMP and regulations, we provide support for preparations for various inspections, as well as measures and improvement proposals for issues raised. We can assist with tasks such as "preliminary equipment diagnostics" and "measures and improvement proposals for raised issues." We can also provide specific advice on how to respond to detailed points and requests, as well as how to explain them, so please feel free to consult with us. [Examples of services we can provide] ■ Preliminary equipment diagnostics ■ Advice on explanation methods (anticipated Q&A) ■ Preliminary responses to potential issues ■ Measures and improvement proposals for raised 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 actively 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 strongly 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 FDA inspection of an aseptic preparation factory ■ Response to FDA inspection for a cosmetic ingredient 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, including validation and calibration, focused 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 from visualizing the challenges faced by each manufacturing site to finding solutions, collaborating with our clients throughout the process.