Support from requirement extraction for regenerative medicine products! Creation of a roadmap through GCTP facility diagnosis.
We support the construction and renovation of pharmaceutical manufacturing facilities related to "regenerative medicine products." Do you have any questions such as: "What requirements must be met to manufacture regenerative medicine products?" "What practical measures should be taken to produce sterile preparations?" We will assist you from the first step of creating the "required facilities" for continuous pharmaceutical production, tailored to your unique needs. 【Do you have any of the following concerns?】 ■ What requirements must be met to manufacture regenerative medicine products? ■ What practical measures should be taken to produce sterile preparations? ■ Is it possible to establish a regenerative medicine product manufacturing facility by renovating existing facilities? ■ If so, what kind of renovation work would be necessary? ■ Is the construction of a regenerative medicine product manufacturing facility worth the investment? *For more details, please refer to the PDF document or feel free to contact us.
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【Example of Output】 ■Layout Change Scope: Confirmation of the area to be renovated ■Work Space: Confirmation of the actual work space ■Preparation Area: Confirmation of the necessity for a preparation area for non-disposable equipment and solutions that require prior preparation ■Human Flow: Confirmation of the entry and exit flow to the work area ■Changing Room Space: Confirmation of the number of entrants and operational methods *For more details, please refer to the PDF document or feel free to contact us.
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[Example of Achievements] ■ Planning of manufacturing facilities for regenerative medicine products *For more details, please refer to the PDF document or feel free to contact us.
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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.