Boudicca DX™
European Union (EU) Focused Regulatory & Quality Consulting Services in Ireland
Accelerate EU Time-to-Trial & Time-to-Market
Reach out to courtney@boudiccadx.com to schedule a 30 minute call to learn more about our EU consulting services.
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BOUDICCA DX LIMITED (LTD)
Ireland Companies Registration Office (CRO) Registration Number: 779741
Private Company Limited by Shares
Registered Address
6th Floor, 2 Grand Canal Square
Dublin 2, Ireland, D02 A342
Trading Address & EU Operations Location for Audits
The Red Church, Unit 7
Henry Street, Limerick, V94 XY20, Ireland
EU Legal Representative Services
- Representative for EU IVDR and EU MDR Performance Evaluation Studies
- Consultants are EU IVDR & MDR regulatory experts
- Support compliance obligations for studies evaluating the scientific, analytical & clinical performance of an IVD or medical device
- Point of Contact for communications with the National Competent Authority(ies) (NCAs)
- Submit and manage NCA submission packages
- Manage NCA Requests for Information (RFIs)
- Generate High-quality NCA submission packages
- PhD-trained consultants with professional IVD & MD working experience prepare documentation
- ASCP clinical laboratory scientists & molecular technologist to support extraction of analytical and clinical performance testing data from CLIA, CAP & NYS-CLEP validation reports
- Extensive & diverse clinical biomarker & Companion Diagnostics (CDx) experience
- Drug development experience to fully understand the clinical trial assay context of use
- Provide appropriate endpoints for Performance Evaluation Studies based on drug clinical trial use
- Accurately Complete General Safety and Performance Requirements (GSPR) Template
- Provide Independent monitoring (ISO 20916 compliant) services
- Streamline & harmonize EU, US & ROW global submissions to reduce costs & timelines
- Save time & money with elimination of additional third party consultants for EU
EU Authorised Representative Services
- Represent manufacturer placing IVDs & Medical Devices on the EU market
- Qualified Person Responsible for Regulatory Compliance (PRRC)
- Support Single Registration Number (SRD) & UDI-DI assignments
- Secure Document Storage (copy of technical documentation, EU declaration of conformity, etc.) in the Limerick Office
CE-marking Support for Notified Body Submissions
- 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 scientists with professional IVD & MD working experience manage & review Technical File Documentation to ensure it provides sufficient objective evidence
- Ensure performance data support the intended use to reduce time to Certificate Decision & RFIs
- Generate & review Intended Purpose statements
- Manage State-of-the-art (SOTA) analysis
- Experts in CLSI Guidelines & ISO standards
- Scientific Literature Reviews
- Generate Summary of Technical Documentation
- Generate Summary of Safety and Performance
- Labeling generation & review
- Medical Writers manage & publish Technical File Documentation (Parts A through K)
- Assessment of Conformity with EU IVDR & MDR procedures
- Accurate completion of General Safety and Performance Requirements (GSPR) Template
- Audit Technical File Documentation using Boudicca DX™ Checklists
- Support EU Reference Laboratory (EURL) Performance Verifications if required
- Support distance sales manufacturers (e.g., US laboratories) with compliance
- Support Structured Dialog with Notified Bodies
- Manage document translations when required
Unparalleled Companion Diagnostics (CDx) Expertise
- 15+ years of EU CDx experience (IVDD > IVDR transition)
- Drug development experience so no learning curve, reducing cost & timelines
- Review Biopharma clinical protocols <24 hr to quickly identify if clinical trial assays are subject to EU IVDR
- Support accurate completion of EU MDR & IVDR section of EU clinical trial application cover letters
- Describe clinical biomarker testing appropriately in Investigational Medicinal Product Dossier (IMPD) and Biopharma clinical protocols to mitigate clinical holds and reduce Requests for Information
- Generate EU IVDR performance evaluation study documentation & manage submissions to NCAs (experience includes Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands & Spain)
- Manage Ethics Committee (EC) submissions
- Experience leveraging local comprehensive genomics profiling and genetics testing for clincial trial eligibility
- Experience leveraging Article 5(5) health institution exemption status & support Biopharma with EU in-house test (IHT) set-up & compliance with GSPRs
- Support clinical biomarker testing decentralization to enable Biopharma to use best-in-class & first-in-class technology for their clinical trials rather than settling for mediocre technology in one CRO laboratory
- Continuous intelligence from supporting 90+ global clinical trials & attending EMA and NCA Scientific Advice Meetings with Biopharma clients
- Support EMA CDx alignments and discussions on whether a CE-marked CDx is required versus a validated test
- Provide Independent CDx biomarker data monitoring services
- Extensive global CDx clinical bridging study experience
- Currently support bridging studies in China, EU, Japan, & US to support EMA, FDA, & PMDA marketing authorisations
- Currently support global clinical trials for rare biomarkers & rare and ultrarare diseases
- Support performance evaluation notifications for bridging studies with leftover samples
- Knowledgeable on the importance of ascertainment rates & global regulatory expectations
- Biostatistician to support negative sampling strategies, sensitivity analyses, imputation & missing data handling in accordance with current regulatory expectations
- Drug development experience so no learning curve, reducing cost & timelines
Quality Compliance Expertise & Auditing
- 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
