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Services: Service
Areas of Expertise
  • Product development following design controls

  • Clinical Study design and execution

  • Production and process controls / GMP

  • Quality systems implementation and adherence

  • Regulatory submissions and interface with regulatory agencies

  • Risk management

  • Portfolio strategy

  • Due diligence assessments

Successfully bringing diagnostic products to market requires an understanding of the governing regulations as well as the practical know how of implementation within a regulated environment. 

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