Regulatory experts you can rely on

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Regulatory strategy and support to meet your specific needs

Global regulatory requirements for in vitro Diagnostics (IVD) are continuously evolving and often diverging.  Companies looking towards IVD (co-)development and commercialization need an established and agile partner that can reduce business, project, and timeline risks. For 20 years, Beaufort has provided comprehensive regulatory affairs consulting and services that anticipate, identify, and respond to emerging challenges and obtain regulatory clearance or approval for our clients.

Our areas of specialty in global regulatory consulting

With our extensive knowledge across all facets of the diagnostic development, trial, and regulatory approval process, we offer comprehensive end-to-end support — from regulatory strategy and protocol development through pre- and post-market submission activities.

Full Service Regulatory Affairs Solutions

  • Strategic assessment of regulatory requirements – global vs. local
  • Submission type(s)
  • Data requirements
  • Quality system requirements
  • Timeline development

  • Intended use/intended purpose statement development
  • Predicate device identification
  • Device classification
  • Device coding and categorization (GIVD, GMDN, EMDN, NBOG)
  • Conformity assessments and requirements

  • Premarket submission development
    •  United States (FDA)
      • Pre-submissions
      • Study risk determinations (SRD)
      • Investigational device exemptions (IDE)
      • Breakthrough device designations (BDD)
      • Emergency use authorizations (EUAs)
      • Humanitarian use device (HUD)/ Humanitarian device exemption (HDE)
      • Premarket notification (510(k))
      • De novo classification requests
      • Premarket approval applications (PMA)
    •  Health Canada IVD medical device license (MDL)
    •  EU (IVDR readiness  & compliance)
      • IVDR technical documentation preparation
      • GIVD, GMDN, EMDN, NBOG Codes
      • IVDR implementation support
        • Technical documentation support and preparation
        • Companion diagnostic performance evaluation support and Annex XIV documentation preparation
    •  EUDAMED Support
      • Device and actor registrations
      • Basic UDI-DI, UDI-DI and UDI-PI
  • Quality system support
  • Post-market support

  • Mock inspections
    •  Quality system audit execution (FDA QSR, ISO 13485, etc.)
    •  Inspection and audit readiness (FDA, Notified Body, ANVISA, etc.)
  • Standard operating procedure development and review
  • Regulatory agency liaison – meeting facilitation
  • Training
  • Due diligence assessments ahead of acquisitions

  • Regulatory intelligence – changing regulatory requirements
  • Impact/gap assessment and transition strategies
  • Remediation recommendations
  • Decision tree analysis support

The proof is in the results

Our extensive regulatory experience includes over 500 global submissions ranging from IDEs and pre-submissions, de novo classifications, 510(k)s, PMAs, and CLIA waivers to IVDR-compliant Technical Documentation submissions and PDMA registrations. What’s more, Beaufort is ISO 9001:2015 certified, ensuring we deliver support and services performed to the highest scientific standards — an important distinction when it comes to selecting the right regulatory affairs partner.

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