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
FDA Inspection Readiness
  • Agency Representation & Negotiation
  • Recalls, Field Corrections & Safety Alerts
  • Warning Letter Responses
  • Compliance Certification
  • Clinical Trials
  • Complaint Management and Reporting
  • Post Market Surveillance and Reporting
  • FDA 483 Responses
  • Corrective Action Programs & Management
  • Import Alert & Detention Removal Programs
  • Consent Decree Programs
  • Monitoring of North America & European Union Regulatory Activities