CRYSTALLINE SOLUTIONS
Third Party Facility Audit, Quality Inspector Training and Compliance Services for the Pharmaceutical, Specialized and Technical Manufacturing Industries
Professional Independent Solutions to Help your Business

 

Crystalline Solutions offers a unique selection of services specifically targeted at helping businesses succeed.  Professional and affordable solutions to differentiate your product, expand your market, improve your manufacturing efficiencies and provide scientific guidance are available within the Crystalline Solutions service offering.

 

Third Party Facility Audit Services

Professional and thorough third party facility audits utilizing over 20 years experience.  cGMP facility audits, complaint investigations, due diligence summaries, efficiency and productivity reviews are part of the Crystalline Solutions third party audit service offering.  Flexible scheduling is available along with expedited report generation to close issues quickly and accurately.  Out team qualifications include Certified Good Manufacturing Practices Certification, Lean Manufacturing Expertese, 5S Efficiency Modeling, ISO Auditing and 20 years as an inspector with the U.S. Food and Drug Administration.  We have consulted for Canadian government and have unsupervised government facility visitor security clearance status (current 2012).

 

Quality Inspector Training Services

  • An exciting new approach to Quality Inspector training - HUMAN CALIBRATION - a cutting edge training method to accurate and reliable attribute inspection. 
  • Why calibration equipment without calibrating the quality inspectors?
  • Applicable to all manufacturing facilities that manually inspect products.
  • Fully ISO and/or GMP Compliant training records provided as well as individual and facility certification.

 www.humancalibration.com

"Calibrating your most valuable asset...People"

Try an online test and see how you are classified - do you over reject? under reject? 

 

Regulatory and Compliance Services

  • Pre FDA Audit Services
  • Post FDA and FD-483 Services
  • Complaint and Recall Investigations
  • USA and Health Canada Regulatory Agent Services
  • USA and Canadian DMF and Facility Registrations
  • TGA Regulatory Agent for Proprietary Ingredient Listing for Marketing in Australia
  • Regulatory Affairs and Quality Scientific Support
  • Food Facility Registration and Prior Notice
  • Tobacco Products Registration
  • Medical Devices

                            

In addition to standard payment methods, online payment and worldwide electronic bank Wire Transfers accepted. 

 

 

USA Mailing Address Canadian Mailing Address
3430E Jefferson Ave Suite V4089 554 Greendale Drive
Detroit, Michigan, USA 48207

Windsor, Ontario, Canada N8S 4A8

Toll Free 866 443 6436 Toll Free 866 443 6436
Mobile 001 519 259 3258 Mobile 001 519 259 3258
EFAX 309 405 0268 EFAX 309 405 0268
Email info@crystallinesolutions.com Email info@crystallinesolutions.com