How an Engagement Actually Works — Step by Step
This section describes exactly what happens — from your first email through final deliverable handoff — so you know precisely what to expect at every stage.
48 hrs
SOW to first deliverable
6
Defined steps, every engagement
100%
Repeat engagement rate
$10M+
Saved across engagements
01
Discovery · Day 1
The 30-Minute Intake Call
One call. No sales pitch. We ask precise questions about your program, timeline, regulatory history, and the specific gap you need filled. You leave the call knowing whether we are the right fit — and if we are, what a scope looks like.
No obligation
Program assessment
Fit determination
Scope preview
02
Scoping · Days 2–3
Scoped Statement of Work
We turn the intake call into a precise statement of work: specific deliverables, timelines, expert assignments, and a fixed or milestone-based budget. No ambiguous retainers. No scope creep by design. You know exactly what you are buying before you sign.
Fixed deliverables
Named expert leads
Clear budget
Defined timeline
03
Mobilization · Day 1 of Engagement
Team Deployed — Immediately
The moment a statement of work is executed, your Boudicca® DX team is activated. No ramp period. No handoff from sales to delivery. The experts who scoped the work are the experts who do the work — with direct access to every team member assigned to your program.
Same-day activation
Direct expert access
Dedicated point of contact
04
Execution · Ongoing
Work Product Delivered in Real Time
Regulatory strategy documents, submission packages, biomarker plans, CDx roadmaps, FDA meeting materials — delivered on the SOW timeline with iterative review cycles built in. AI-assisted workflows allow us to move faster than traditional consultancies, with expert review mandatory at every step.
Iterative review cycles
AI-assisted drafting
Expert-reviewed outputs
Public data only
05
Representation · As Needed
FDA & Global Regulatory Interactions
Where scope includes regulatory agency interactions — FDA pre-submission meetings, EMA scientific advice, MHRA consultations — Boudicca® DX leads all briefing material preparation and participates directly in meetings on your behalf or alongside your team.
Briefing document authorship
Meeting preparation
FDA · EMA · MHRA · PMDA
Direct participation
06
Handoff · Engagement Close
Clean Handoff. Lasting Capability.
At engagement close, your team holds every work product, every strategic rationale, and a clear path forward — documented so the knowledge stays with you. Most clients re-engage. When they do, there is no ramp. We pick up exactly where we left off.
Full documentation transfer
Strategic rationale captured
100% repeat engagement rate
From first contact to first deliverable in 48 hours.
For urgent regulatory questions, FDA meeting prep, or program-critical strategy, we mobilize immediately upon SOW execution — no onboarding delay, no implementation timeline.
What You Receive
Regulatory Strategy Documents
Submission-ready strategies for FDA, EU IVDR, MHRA, PMDA and other jurisdictions — with rationale documented at every decision point.
CDx Development Roadmaps
Companion diagnostic plans from preclinical biomarker hypothesis to global IVD approval — with timelines, decision trees, and budget implications.
FDA Submission Packages
BDD requests, Pre-Sub packages, IDE submissions, De Novo requests, 510(k) and PMA strategy documents — authored to FDA standards via eStar templates.
EU IVDR Documentation
Performance evaluation study applications, MDCG 2022-19 compliant documentation, Article 5(5) in-house exemption strategies, and EU competent authority packages.
Biomarker & Analytical Plans
Biomarker strategy documents, analytical validation plans, clinical bridging study designs, and assay development roadmaps.
Reimbursement & Market Access
Payer landscape assessments, MolDX dossiers, ADLT pathway planning, and global market access frameworks — integrated with regulatory strategy from day one.
How We Compare
| Dimension | Traditional consultancy | Boudicca® DX |
|---|---|---|
| Who does the work | Senior partners sell; junior staff execute | The expert who scoped it does it |
| Time to first deliverable | Weeks — onboarding, resourcing, ramp | 48 hours from SOW execution |
| Scope & budget clarity | Open-ended retainers; scope creep common | Fixed deliverables and budget before you sign |
| CDx depth | Generalist regulatory teams | 15+ years hands-on CDx co-development |
| AI integration | Not available or not disclosed | Claude-powered workflows · expert review at every step |
| Market access | Separate engagement, separate firm | 20+ years reimbursement expertise, integrated |
| Knowledge transfer | Knowledge stays with the consultancy | Full documentation — your team keeps everything |
Key insight
An on-demand team is only as valuable as its ability to mobilize without friction. Boudicca® DX was built for the moment when the cost of delay is measured in months and millions — when you need expert judgment today, not after a three-week onboarding. Every element of our engagement structure is designed to eliminate the gap between when you need help and when expert help actually arrives.
Ready to discuss your program?
30 minutes, no obligation.
Access to emerging talent, fresh regulatory intelligence, academic network
US Regulatory Science internships offered to graduate students and postdoctoral fellows through the Vanderbilt BRET Office of Career Development ASPIRE Program.
EU Regulatory Affairs internships offered to MSc students in the UCD Regulatory Affairs program, providing hands-on industry experience.
Our Commitment to Quality
At Boudicca® DX, quality underpins every client engagement. We operate in accordance with a Quality Management System, ensuring that our services consistently meet the highest standards of scientific rigor, regulatory accuracy, and client-centered excellence.
All consultants operate under NDAs, with CVs and certifications on file to support your vendor qualification and purchasing control compliance requirements. All CRO services are executed with the highest commitment to Quality.
For quality documentation requests, please contact us at courtney@boudiccadx.com.
