Consulting Services
On-demand precision medicine expertise across development, regulatory, and commercialization — deployed immediately, wherever you are in the world.
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01
Translational Science
End-to-end biomarker strategy from bench to bedside — CDx co-development, pharmacodynamic biomarkers, DDTs, and grant writing.
02
Clinical Laboratory Testing
Full-cycle CLIA LDT development and commercialization — CAP, ASHI, NYS-CLEP accreditation, FDA single-site IVD pathways, and reimbursement.
03
Product Development & Quality
Full-cycle IVD, medical device, SaMD, and CDx development — analytical and clinical validation, 21 CFR Part 820 compliance, and ISO-certified quality auditing.
04
US FDA Regulatory
Full submission spectrum — 510(k), PMA, De Novo, BDD, IDE, SteP, Q-Sub, HDE — plus IND biomarker content, BIMO participation, and ex-US specimen compliance.
05
EU IVDR & MDR
Ireland-based EU legal and authorized representative services — CE-marking, performance studies, Article 5(5) compliance, Notified Body submissions, and EMA CDx alignment.
06
Global Regulatory
Submissions and RFI management across nine global markets — TGA, ANVISA, Health Canada, NMPA, PMDA, MFDS, MEDSAFE, Swissmedic, and MHRA.
07
AI-Assisted Regulatory Intelligence
Claude-powered regulatory research — rapid synthesis of FDA, EMA, and MDCG guidance; EU/US requirement comparisons; SOTA literature searches. Public data only. Expert review at every step.
08
Competitive Intelligence & Investment Diligence
Actionable diligence for investors and biopharma — clinical, commercial, quality, regulatory, and technical dimensions across IVD and medical device portfolios.
Managed CRO partner
09
Clinical Trial Execution (CRO)
Full-service CRO via our managed partner — trial design, site qualification, monitoring, data management, and biospecimen logistics. Fully managed by Boudicca® DX.
All services available on-demand — ad hoc, project-based, or retained fractional. Questions about scope or fit? Talk to an expert →
Translational Science
For biopharma and biotech teams developing biomarker strategies, clinical trial assays, and companion diagnostics from preclinical through regulatory submission.
End-to-end biomarker strategy from bench to bedside — executed by PhD scientists with verifiable drug development and assay development and validation experience across all BEST biomarker types.
Need Translational Science support? → courtney@boudiccadx.com
Clinical Laboratory Testing
For CLIA laboratories, clinical labs seeking FDA clearance, and biopharma sponsors managing central laboratory testing in clinical trials.
Full-cycle CLIA LDT development and commercialization — with certified laboratory professionals who execute diligence at both the bench and documentation level.
Need Clinical Laboratory Testing support? → courtney@boudiccadx.com
LDT, CTA & IVD Analytical Validation Training
Product Development
For IVD manufacturers, medical device developers, and digital health companies moving from concept through commercial launch and quality compliance.
Full-cycle support across IVDs, LDTs, medical devices, SaMD, DHTs, CDSTs, DDTs, and MDDTs — from first labeling review through commercialization, reimbursement strategy, and post-market surveillance.
- Analytical & clinical validation — study design and execution; decades of hands-on experience across all major assay and device platforms
- Regulatory labeling reviews — RUO and IUO labeling for investigational products
- QMSR / 21 CFR Part 820 compliance — design control, process validation, risk management, V&V
- Biostatistics support — GLP and GCP-compliant study designs and statistical analysis plans (SAPs)
- Clinical sample sourcing — via ISO 20387-accredited biobanking network; ICF reviews and IRB submissions
- IVD and device clinical trial monitoring — through our preferred CRO network
- Reimbursement strategy — clinical utility studies, payer strategy, commercialization planning
- Usability engineering — human factors study design and documentation per IEC 62366
Need Product Development support? → courtney@boudiccadx.com
US FDA Regulatory
For IVD developers, CDx sponsors, biopharma regulatory teams, and clinical laboratories navigating FDA submissions, IDE compliance, and inspection readiness.
US-based regulatory agent services with former FDA CDRH reviewers on staff — covering the full IVD and medical device submission spectrum, prepared in the least-burdensome manner using eStar templates via the CDRH Collaboration Portal.
Submissions
- 513(g) requests for information
- Q-submissions — Breakthrough Device Designations (BDD), Pre-submissions, Information Meetings, STeP requests, Significant Risk Determinations (SRDs)
- IDEs — amendments, supplements, and annual reports
- HDEs — Humanitarian Device Exemptions
- 510(k)s — abbreviated, special, and traditional
- PMAs and sPMAs — Premarket Approvals and supplemental PMAs
- De Novo requests
IND & Biomarker Support
- Interact, Pre-IND, and IND content — investigational IVDs, CDx assay amendments, cut-off determination rationale, algorithm validation reports
- Streamlined IND Study Risk Determinations (SRDs) — IDE exempt, NSR, or SR determinations
- Ex-US specimen testing compliance for US laboratories supporting global trials
- EOP briefing book preparation and FDA meeting management
Inspection & Advisory
- PAI and BIMO inspection support
- Mock regulatory advisory boards
- Regulatory education workshops
- IRB submissions and ICF reviews
- FOIA requests — to reconstruct regulatory history
Need US FDA Regulatory support? → courtney@boudiccadx.com
Quality Compliance
For CDx and IVD manufacturers, medical device companies, CROs, and clinical laboratories preparing for FDA inspections, Notified Body audits, or internal quality system improvements.
Expert quality auditors and regulatory compliance specialists — with former FDA CDRH reviewers on staff and 25+ years combined experience across BIMO and PAI inspections. Boudicca® DX provides ISO 13485:2016-certified quality auditors with Lean Six Sigma credentials, PhD-trained technical auditors, and QMSR-fluent compliance experts who audit across the full precision medicine product development ecosystem.
- Audit scope — DHF/TMF reviews · supplier and OEM audits · GCP clinical trial testing · QMS (ISO 9001, ISO 13485, ISO 15189) · 21 CFR Part 820 (QMSR) · software (ISO 27001, ISO 42001, IEC 62304) · instrumentation (IEC 61010/61326) · IQ/OQ/PQ · risk management (ISO 14971)
- Client types audited — CDx manufacturers, IVD manufacturers, medical device manufacturers, CROs, GCLP laboratories, GLP non-clinical study sites
- Mock FDA PAI and BIMO inspections — front room and back room support to identify and remediate findings before agency visits
- QMSR expertise — 21 CFR Part 820 Quality Management System Regulation compliance for US-marketed devices
Need Quality Compliance support? → courtney@boudiccadx.com
Global Regulatory
For biopharma sponsors, IVD manufacturers, and CDx developers managing multi-market submissions and global clinical trial compliance.
Decades of experience handling regulatory submissions and RFIs across nine global markets — with extensive experience in global CDx submissions, clinical bridging studies, and multi-jurisdiction approvals.
Markets
- Australia — TGA
- Brazil — ANVISA
- Canada — Health Canada
- China — NMPA
- Japan — PMDA
- Korea — MFDS
- New Zealand — MEDSAFE
- Switzerland — Swissmedic
- United Kingdom — MHRA (including CTA submissions, checklist and tabular summary format)
Global CDx Strategy
- Global CDx regulatory strategy — harmonized multi-jurisdiction approach from a single clinical dataset
- CDx clinical bridging study design and execution — with biopharma and CDx manufacturer partners
- Multi-jurisdiction CDx approvals — US FDA, PMDA, NMPA, EMA; simultaneous or sequential
- EU IVDR performance study applications — other competent authority submissions per MDCG 2022-19
Need Global Regulatory support? → courtney@boudiccadx.com
AI-Assisted Regulatory Intelligence
For regulatory affairs teams, biopharma sponsors, and IVD developers who need faster, more current regulatory intelligence without compromising quality or client confidentiality.
Boudicca® DX uses Claude by Anthropic to synthesize publicly available regulatory information at speed — with mandatory expert consultant review at every step. No client data. No proprietary strategies. Public regulatory information only.
- eStar template compilation and cross-referencing — FDA IDE, 510(k), De Novo, PMA submission requirements
- EU/US regulatory comparison — side-by-side analysis of IVDR and FDA analytical validation terminology, performance study expectations, and submission documentation standards
- State-of-the-art (SOTA) literature searches — AI-assisted, executed by PhD-trained scientists for EU IVDR, EU MDR, UK MHRA, US FDA, and ROW submissions
- Continuous regulatory monitoring — FDA, EMA, MDCG, Notified Bodies, UK MHRA, and ROW guidance updates tracked in real time
- Public database synthesis — 510(k) databases, De Novo summaries, PMA records, and regulatory decision summaries to inform study designs
- Expert gap review — all AI-assisted outputs reviewed by expert consultants before delivery
AI synthesizes from current regulatory guidance documents in real time. Unlike static navigators, no software license is required — keeping regulatory intelligence costs low for clients.
Need AI-Assisted Regulatory Intelligence? → courtney@boudiccadx.com
Competitive Intelligence & Investment Diligence
For investors, acquirers, and biopharma business development teams evaluating precision medicine assets, diagnostics companies, and IVD programs.
Twenty-plus years of precision medicine product development experience translated into actionable investment diligence — covering clinical, commercial, quality, regulatory, and technical dimensions to de-risk multi-million and billion-dollar decisions.
- Investment diligence — 20+ engagements supporting medical device and IVD diligence across clinical, regulatory, quality, and commercial dimensions
- Competitive landscape assessments — technology, regulatory, and commercial vantages across diagnostic and therapeutic programs
- AI-assisted public database mining — for clinical, technical, regulatory, and commercial intelligence
- FOIA requests — deeper dives into non-public regulatory history for diligence purposes
- Fractional portfolio company placement — BDX consultants available for ongoing post-investment support within portfolio companies
Need to de-risk your investment? → courtney@boudiccadx.com
Contract Research Organization (CRO) Services
Boudicca® DX has partnered with Global BioClinical (GBC), a precision medicine-focused CRO with 20+ years of experience designing, initiating, and managing complex IVD, companion diagnostic, and medical device clinical trials. GBC specializes in the full spectrum of clinical research — from trial feasibility and protocol design through site qualification, monitoring, data management, biospecimen logistics, and regulatory submission support.
All CRO services are fully managed by Boudicca® DX — ensuring complete harmonization of clinical strategy, regulatory strategy, and CDx development planning under a single point of accountability. Clients receive competitive costing and direct access to Boudicca® DX's regulatory intelligence alongside GBC's operational expertise, without managing two separate vendor relationships.
One relationship. Fully integrated clinical and regulatory execution.
Most biopharma and IVD companies manage their CRO and regulatory consultant separately — creating gaps between clinical trial design and regulatory strategy that cost time and money. Boudicca® DX manages the GBC relationship directly, so your clinical trial design, IVD regulatory submissions, and CDx development strategy are built together from day one.
Full-service CRO capabilities
Trial Design & Management
- ICH-GCP compliant protocol development
- Trial feasibility assessments
- Inclusion/exclusion criteria design
- IRB / Ethics Committee submissions
- Clinical site qualification and start-up
- On-site and remote risk-based monitoring
- Trial Master File (TMF) management
- Project management and milestone tracking
Data Management
- eCRF design and cloud EDC database management
- Data management plans and QC
- Data adjudication and reconciliation
- Biostatistics and statistical analysis plans (SAPs)
- GCP-compliant reporting
Biospecimens & Logistics
- Prospective biospecimen sourcing
- Retrospective sample identification and qualification
- Collection kit design and labeling
- Central laboratory management
- US and EU import/export and shipping logistics
- Biostorage coordination (LN₂ through ambient)
- Biorepository design, operations, and CAP accreditation guidance
Trial types supported
Clinical Performance & Pivotal Studies
Feasibility & Proof of Concept Studies
Post-Approval & Post-Market Studies
Regulatory frameworks covered
ICH-GCP
GCLP
ISO 20916
ISO 14155
US IRB
ROW Ethics Committees
Adverse Event Reporting
Why this matters
Clinical trial execution and regulatory strategy are not separable for IVD and CDx programs. The decisions made in trial design — endpoint selection, sample collection protocols, central lab qualification, data management plans — directly determine whether a regulatory submission succeeds. By managing the GBC relationship directly, Boudicca® DX ensures that every clinical operations decision is made with the regulatory outcome already in view.
Need CRO services for your IVD, CDx, or medical device program?
Get in touch →