Regulatory strategy, submission and market access.
The whole regulatory arc under one team: the route to approval decided before the first site opens, and the submission, health-economic and payer work that turns results into a decision.
The work, made concrete.
Not a service brochure, the actual scope, the actual deliverables, and how it plugs into ECS®.
- Regulatory pathway assessmentWhich framework applies, ICH E6(R3), EMA/FDA, MDR/IVDR or the consumer-health route, and what each one demands of the design.
- Feasibility & country selectionWhere the population actually is, what each country costs in time, and which combination hits the timeline.
- Site landscape & qualificationSite identification, capability screening and readiness assessment before commitments are made.
- Submission planningCompetent authority and ethics submissions sequenced country by country, with dependencies made visible.
- Regulatory submissionCTD Modules, MDR CER / PMCF plans, EFSA / FDA claim dossiers, assembled and defended through review.
- HEORHealth-economic models, budget impact analyses and cost-effectiveness studies, for the payer archetypes that matter in your markets.
- Market accessValue story, evidence gap analysis for HTA bodies, and access dossiers for national and regional payers.
- Post-approval evidenceReal-world evidence programmes designed for label maintenance, re-assessment and access defence.
Every deliverable has a name on it.
What you receive.
Every engagement lands with named artefacts you can use.
- Regulatory pathway memo with framework rationale
- Feasibility report and country/site shortlist
- Site qualification summaries
- Submission calendar with dependencies and risk notes
- Regulatory submission package (CTD / MDR / claim-dossier as applicable)
- HTA / payer value dossier and health-economic model with adaptable inputs
- Post-approval evidence plan
Feasibility signals, site qualification records, submission milestones and post-approval studies all live in the same ECS® ecosystem, so the regulatory plan, the operational plan and the access evidence never drift apart.
Three moments this service earns its place.
If any of these describe where you are, this is the right entry point.
- Moment 01
You have a protocol concept and no confirmed regulatory route.
- Moment 02
Recruitment assumptions need a hard feasibility check before budget lock.
- Moment 03
You're entering a new region and need the country strategy sized properly.
- Moment 04
You're preparing an approval or a label extension.
- Moment 05
Access has stalled and the evidence story, or the economic model, needs strengthening.
Often engaged together.
Evidence strategy & study design
Map the evidence path, position the product scientifically, and design protocols and endpoints across every domain and product class.
Learn moreProtocol development & scientific writing
Turn your idea into a regulator-ready protocol, rigorous, defensible, submission-grade.
Learn moreMedical & scientific writing
Study reports, manuscripts, abstracts, lay summaries and dossiers, with publication planning and scientific communication that carries the evidence forward.
Learn moreTalk to the team about this service.
Tell us the study or the question, we'll come back with a scoped answer.