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Clinical Diagnostics Regulatory Affairs: IVD/CDx

Clinical Diagnostics Regulatory Affairs provides a full range of clinical affairs and regulatory affairs writing and submission services for 91黑料 Labs’ developed IVD products used in pharmaceutical clinical trials. This includes consultation on regulatory strategy related to IVD device products used in clinical trials, document writing, electronic formatting, publishing and submission. We also coordinate needed US-domestic and/or OUS device study submissions and records management. 

We provide full IVD regulatory affairs and device controls for 91黑料 Laboratories’ in-house developed assays to support your customised pharmaceutical clinical trial needs including;

  • Full Design Controls
  • Pilot phase Manufacturing and Labelling under device Quality Management
  • Validation to ease bridging study burden
  • Pre-Submissions and Regulatory Strategy
  • Study Risk Determinations
  • Clinical Affairs including Ethics Committee/Investigational Review Board (EC/IRB) submissions
  • Investigational Device Exemption Applications (US-IDE) and Performance Study Applications (EU-PSA)
  • Registrations associated with collection kits
  • Market authorisation, and all other full partner activities up to large scale manufacturing and distribution.

Our Regulatory team also offers consultation on Regulatory Compliance and Device Quality Management System requirements, particularly Design and Development, to reduce the need for bridging studies and to enable smooth transition to large scale manufacturing partnerships. 

We have direct experience consulting on the global intersect of regulation and standards related to;

  • Use of assays in clinical trials
  • Design and pilot-scale manufacturing of assay products
  • Regulatory roles and submissions including registrations and provision of testing laboratory services including with investigational assay products. 

The team supports clients with these items from a full partnership approach.

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