Why BioTeknica?

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Because the probability of success increases the earlier and more thoroughly you prepare – and our proven methodologies fully prepare your organization for any regulatory challenge. We provide client solutions that are…


…and, we

  • Specialize in regulatory complianceFDA inspection readinessquality engineering, and validation projects for the Medical Device, Biologics, and Pharmaceutical industries
  • Provide resolution to FDA compliance, regulatory and validation issues
  • Bring proven industry experience and expertise – we are comprised of seasoned and highly skilled industry professionals who possess diverse skills and a full range of multi-disciplinary talents
  • Provide hands-on, cost effective quality solutions and guidance through every stage of the manufacturing process
  • Understand your business and adapt to your needs.  We’re familiar with the industry’s production equipment, product development, processes, and quality systems which means minimal learning curve costs
  • Partner with you and serve as extension of your team, supplementing your company’s resources to provide expertise in critical areas