New Bio-pharmaceutical and Medical manufacturing facilities and plant establishment projects include design and new manufacturing technologies development. Biotech/Pharmaceutical/Medical/Cosmetic projects management require wide theoretical knowledge combined with practical experience in the unique characteristics of these industries. A new Bio-pharmaceutical, Medical manufacturing facility project management which adopts common Engineering and Management methodologies, may not succeed. Understanding the regulatory requirements deeply, the ability to generate and present relevant documents to the relevant regulatory authorities, using the relevant Bio-Med and engineering project management methodologies, integration of the relevant Quality principles within the project management team, engineers and contractors are mandatory for supplying a safe product that comply the the quality and regulatory standards. The main challenge is that the new Pharma / Medical facility, manufacturing technology and processes will meet all the regulatory requirements including Commissioning, Qualification and Validation stages. From the beginning until the final project stage, Bio-Chem will lead you to a successful regulatory body facility audit, official facility certification and marketing approval.
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