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Your success is important to us

As an industry leader, we confront the same challenges you face as a Diagnostics or BioPharma manufacturer. We have pioneered paths to success, overcoming roadblocks with knowledge and lessons learned through decades of experience, and we share that know-how with you. From business and regulatory issues to production troubleshooting, we help safeguard your operations and market standing with fast answers to problems, anytime and anywhere.

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CustomBiotech Nanoparticles

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Your security - the reason for our stringent quality standards

The CustomBiotech Quality Management System (QMS) is based on ISO 13485 certification. This international standard requires an organization to consistently meet customer and regulatory requirements relevant to the in-vitro diagnostic and medical device industry.


Our raw material and final kit production follows strict quality measures ensured by:
  • Detailed documentation (SOPs, central documentation)
  • Batch records with full traceability of all parameters
  • Independent QC and QA departments
  • Change control procedures
  • Complaint handling procedures
  • Education and training programs
  • Supplier evaluation programs
  • Maintenance and calibration programs

ISO 13485:2016 certificate for Roche Diagnostics GmbH in Penzberg, Germany

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