we are your mentors in

Validation & Compliance

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We have successfully supported projects in Puerto Rico, 
Continental USA, Latin America and Europe.

135+ Experienced Resources Serving the Life Science Industry
such as Pharmaceutical, Biotechnology and Medical Devices. 

 

 

services


 
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Commissioning & Qualification

  • Facilities & Utilities (Water, Gases, Environmental)
  • Equipment & Systems (Manufacturing,Packaging & Laboratory)
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Automation, IT & IS

  • Building Systems
  • Process Automation
  • Information Systems Validation (LIMS,ERPs,DCA,SAP,Etc.)
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Project Management

  • C&Q Capital Projects
  • Construction
 
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Regulatory Compliance

  • Investigations / CAPA Implementation
  • Compliance Audits (Supplier, Systems and Pre-Inspection)
  • Technical Writing and Documentation Systems
  • Quality Systems
  • Quality Risk Management
  • Remediation Plan Development
  • Remediation Support
  • APRs, CC, NDA, ANDA
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Validation

  • Technology/Product Transfer in Pharmaceutical, Bio-Technology and Medical Device industries
  • Process Validation
  • Cleaning Validation
  • Packaging and Packaging Process Validation
  • Computer Systems Validation (Software and Hardware)
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    Laboratory Support

    • Bench Personnel for analytical and microbiology laboratory operations

    • Methods Development, Transfer and Validation

    • Laboratory Equipment Validation

    • Laboratory Information Management System (LIMS) Validation

    Curious about
    what else we can
    do for your business?

    Learn more about
    our variety of services

     
     
     

    Need a Mentor?

    OUR EXPERTS ARE READY TO HELP
    WITH YOUR NEXT PROJECT.

     
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