Your Technical Liaison from CONCEPT to IMPLEMENTATION

Regulatory

Operational Review     

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  • Product Development   • Risk Analysis
  • Sterility Validation   • Statistical Process Control
  • Vendor Audits   • Cleaning Validation
  • Equipment, Facility, &
   Software Assessment 		  • ICH, ISO9000 & EN46000 Pre-
   Assessment Baseline Audits
  • High Potency Manufacturing
   and Chain of Custody		   • Reliability, Manufacturing, &
   Maintainability
  • Design Control  
   

Issues Management

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  • Compliance Management   • FDA 483 Responses
  • Warning Letter Responses   • Quality Systems Documentation
   Programs
       

|| HOME  || OUR FOCUS || QUICK TOUR || TECHNICAL ||
|| REGULATORY || ENGINEERING || VALIDATION || CONTACT US ||

102 Poplar Knoll Court
Cary, NC
27519-5611

Telephone: (919) 303-9512
Cell: 919-801-0221
Fax: 775-314-7866
E-mail: info@moebusindustries.com

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