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Regulatory affairs

regulatory affairs

A smart Regulatory Affairs (RA) strategy will shorten the time-to-market of your drug or medical device.  And, the RA successes will strongly determine the commercial success of your product. With this in mind, Xendo delivers high level regulatory services in all phases of the life cycle: from early-stage development to market authorization and post-approval stages.

Contact regulatory affairs

For pharmaceutical products:
Ineke Jonker-Hoogerkamp, business unit manager
-    Telephone: +31 (0)71 524 40 00
-    Email: ineke.jonker@xendo.com

For medical devices:
Marc Klinkhamer, competence center manager
-    Telephone: +31 (0)71 524 40 00
-    Email: marc.klinkhamer@xendo.com

Scope of services regulatory affairs (pharmaceutical products)

  • Regulatory affairs strategy
  • Pre-approval
    • Investigator’s brochure
    • Clinical trial application (e.g. IMPD)
  • Market authorization application
    • Regulatory submissions (CTD and conventional)
    • DMF
    • EP Certificate of suitability application
    • Expert reports
    • CTD (quality) overall summaries
    • Labelling
    • Interaction with regulatory authorities
  • Post-approval
    • Variations and renewals
    • Submissions for extended drug development activities (abridged applications)
    • Periodic safety update report

Scope of services regulatory affairs (medical devices)
  • Compliance with the European Union legislation:
    • Active Implantable Medical Device Directive 90-385EC
    • Medical Device Directive 93-42EC
    • In Vitro Diagnostic Medical Device Directive 98-79EC
  • Compliance with FDA regulations (21CFR820 and others)
  • Risk management, during design and development projects
  • Clinical trials support
  • Regulatory submissions:
    • EU technical files
    • EU competent authority registration
    • FDA 510(k) filing
    • FDA Pre Market Approval (PMA) filing
  • Post marketing surveillance and vigilance
  • Authorized representative for non EU manufacturers