Bioteknica is a consulting firm specializing in engineering, quality, and regulatory projects
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Engineering
Operational Review
Issues Management
Technical/Developmental Services
IS/ IT Information Systems Management
Design & Construction
  • Product Development Management
  • Product Development Services
  • Process Robustness Assessment
  • EU Submissions & Registration
  • 510(k), PMA and BLA Submissions
  • Bio-Statistics
  • cGMP Risk Analysis
  • Reliability, Manufacturing & Maintainability
  • Vendor & OEM Audits
  • ISO 9000 & EN 46000 Pre-Assessment Baseline Audits
  • Design Control
  • Process, Equipment, Facility & Software Assessment