Boudicca® DX European Union (EU) Regulatory Consulting Services
EU IVDR and EU MDR Experts Based in the EU with Extensive Experience Interacting with National Competent Authorities & Notified Bodies
Our Expert Consultants Accelerate EU Time-to-Trial & Time-to-Market for IVDs & Medical Devices
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BOUDICCA DX LIMITED
Ireland Companies Registration Office (CRO) Registration Number: 779741
EU Private Company Limited by Shares
Registered Address (Company Secretary is William Fry, a leading Irish corporate law firm)
6th Floor, 2 Grand Canal Square
Dublin 2, Ireland, D02 A342
Trading Address & EU Office Operations
The Red Church, Unit 7
Henry Street, Limerick, V94 XY20, Ireland
EU Legal Representative Services
- Provide representation for EU IVDR and EU MDR clinical performance studies
- Consultants are EU IVDR & MDR experts qualified as a Person Responsible for Regulatory Compliance (PRRC)
- Support compliance obligations for studies evaluating the scientific validity, analytical & clinical performance of IVDs & medical devices
- Direct Point of Contact for communications with the National Competent Authority(ies) (NCAs)
- Submit and manage NCA submission packages for clients
- Manage NCA Requests for Information (RFIs) & provide insights from continuous regulatory intelligence
- Generate high quality, technically-strong NCA submissions
- PhD-trained professionals with continuous IVDR & MDR experiences
- Provide guidance on analytical performance study designs & appropriate acceptance criteria
- Experts in analytical validation study design (decades of experience)
- On Demand Biostatistician with deep global IVD & medical device experience
- Least burdensome mindset to mitigate timeline delays & costs
- ASCP-certified molecular technologist to support extraction of analytical and clinical performance testing data from CLIA, CAP & NYS-CLEP assay molecular testing validation reports in the US laboratories to support EU IVDR documentation
- Advise on appropriate endpoints for Performance Studies based on extensive IVD and medical device experience
- Complete General Safety and Performance Requirements (GSPR) Template
- Extensive experience with both single-site IVDs and distributed/kitted IVDs & understand how to present these distinct IVDs to the NCAs to mitigate RFIs & timeline delays
- Extensive experience with medical device clinical investigations & advise on minimal content
- PhD-trained professionals with continuous IVDR & MDR experiences
- Support monitoring of clinical performance studies (ISO 20916 compliance)
- Streamline & harmonize EU, US & ROW global submissions to reduce costs & timelines for our clients to preserve runway for global clinical development & launch
- Provide guidance on global regulatory expectations to be able to design globally acceptable studies & to understand risks based on differential regulatory expectations
EU Authorised Representative Services
- Represent manufacturer placing IVDs & Medical Devices on the EU market
- Ireland-based Consultants are Qualified Person Responsible for Regulatory Compliance (PRRC) with all qualifications on-file in the Boudicca® DX Quality Management System
- Support Single Registration Number (SRD) & UDI-DI assignments
- Secure Document Storage (copy of Technical Documentation, EU declaration of conformity, etc.)
Notified Body CE-marking
- Product classification support
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- MDR Class I, Class IIa, Class IIb or Class III
- IVDR Class A, Class B, Class C or Class D
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- PhD-trained professionals with IVDR & MDR experience manage & review Technical Documentation
- Generate & review Intended Purpose statements
- Ensure performance data support the Intended Purpose
- Manage State-of-the-art (SOTA) analysis & documentation
- Experts in EU-recognized standards for IVDs & MDs
- Scientific Literature Reviews executed by PhD-trained scientists
- On Demand Anatomic, Clinical & Molecular Pathology input available
- Generate Summary of Technical Documentation (STED)
- Generate Summary of Safety and Performance
- Generate Labeling
- Medical Writing Consultants manage & publish Technical Documentation
- Assessment of Conformity with EU IVDR & MDR procedures
- Accurate completion of General Safety and Performance Requirements (GSPR) Template
- Extensive GSPR experience with IVDs & MDs
- Support EU Reference Laboratory (EURL) Performance Verifications if required
- Support distance sales manufacturers (e.g., US, UK laboratories, etc.) with compliance
- Support Structured Dialogue meetings with Notified Bodies
- Manage Notified Body contracting
- Manage document translations
Unparalleled EU Companion Diagnostics (CDx) Expertise (15+ years during IVDD to IVDR transition) with Both Prospective & Retrospective (Bridging) Development Experience & Aligning with EMA on the Regulatory Requirement for a CE-marked IVD for the Authorised Therapy
- EU Clinical Trial Support
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- Review Biopharma clinical protocols <24 hours to identify if biomarker assays are subject to EU IVDR
- Reviewed 200+ clinical protocols for clients since onset of EU IVDR
- Provide recommended language for biomarker testing based on context of use
- Provide recommendations on in-house & performance study approaches for biomarker testing
- Reduce National Competent Authority RFIs, costs, & clinical trial timeline delays
- Review Informed Consent Forms (ICFs) to ensure false negative & false positive biomarker testing risks are addressed
- Support sample banking and planning to support CDx bridging studies
- Experience with allcomers (unselected) & biomarker-selection clinical trials in EU & National Competent Authority expectations for both approaches
- Provide rationale for the clinical trial study designs based on the therapeutic mechanism of action & biomarker approach (scientific validity) from decades of clinical biomarker & CDx experience
- Provide cut-off selection rationale based on extensive experience with biomarker selection approaches
- PhD-trained scientists with hands-on drug development experience
- Experience with rare and ultra-rare disease clinical trials, e.g., for gene therapies
- Support accurate completion of EU IVDR section of CTR clinical trial application cover letters
- Describe clinical biomarker testing appropriately in Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB)
- Extensive experience in Clinical biomarkers, Companion Diagnostics (CDx), & Translational Science to quickly provide guidance on biomarker & CDx approaches
- PhD-trained scientists with extensive drug development experience to understand the clinical trial context of use for the biomarker testing along with regulatory expertise
- Knowledge on EU Clinical Trial Application (CTA) requirements & expectations for submissions
- Support EU IVDR performance study documentation for interventional biomarker testing
- Integrated Monitoring (ISO 20916 compliance) to reduce burden & costs
- Manage submissions to National Competent Authorities for clients
- Manage Ethics Committee (EC) submissions
- Experience leveraging local comprehensive genomics profiling testing & genetics testing for eligibility
- Experience leveraging Article 5(5) health institution exemption status
- Support Article 5(5) In-house testing set-up & GSPR compliance
- Continuous regulatory intelligence from supporting 200+ EU clinical trials & attending EMA CHMP and National Competent Authority Scientific Advice Meetings with Biopharma clients
- Review Biopharma clinical protocols <24 hours to identify if biomarker assays are subject to EU IVDR
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- Commercial CDx Support
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- Support EMA CDx discussions on whether a CE-marked CDx is required for the authorised therapy
- Support EMA MAA biomarker content writing & justification for CDx approach, e.g., CE-marking or use of validated tests for the authorised therapy
- Support CDx manufacturers with CE-marking & Notified Body submissions if pursued
- Review Technical Documentation
- Support Structured Dialogue meetings
- Support EMA consultations during conformity assessment
- Manage RFIs
- Extensive global CDx clinical bridging study experience
- Supported bridging studies in China, EU, Japan, & US for EMA, FDA, & PMDA for marketing authorisations for globally-approved therapies
- Performance evaluation notifications for bridging studies using leftover samples
- Biostatistician to support ascertainment rate alignments and to provide negative sampling strategies, sensitivity analyses, imputation & missing data handling in accordance with current regulatory expectations
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Certified & Qualified Consultants Support Compliance
- ISO 13485 Medical Devices Quality Management System
- ISO 9001 Quality Management Systems
- ISO 20916 Clinical Performance Studies
- ISO 14971 Risk Management
- ISO 14155 Clinical investigation of medical devices for human subjects GCP
- ISO 15189 Medical Laboratories Requirements
- ISO 27001 Information security, cybersecurity and privacy protection
- ISO 42001 Artificial Intelligence Management System (AIMS)
- IEC 62304 Software Life Cycle Process
- ISO 19011 Auditing Management Systems
- Support Software Development Plans, Requirements Analysis, Architectural Design, Unit Implementation, Verification, Integration Testing, Systems Testing, Release & Risk Assessment
- AI/ML Risk Management
- Train-Test-Deploy Documentation
- AI/ML Requirements
- Verification & Validation
- Electrical safety & electromagnetic compatibility
- Mechanical & Thermal Risks
- GCP
- Implementation & Audits
- Apply Quality by Design (QbD) approach
- Consultants have extensive experience with working with small start-ups with limited resources
