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Regulatory roadmap in clinical phase
Continuous adjustment of the regulatory pathway as your Phase I, II and III data progresses.
The CRO trusted by teams that can't afford to get it wrong
Your regulatory roadmap in clinical phase, aligned with the EMA at every milestone
As your clinical data progresses, your regulatory strategy has to evolve with it. We design a tailored plan, adapted to your company's budget, and support you step by step through to registration — we don't hand you a report and disappear.
EMA scientific advice
Endpoint alignment
Orphan drug designation
Centralised procedure
Request a meeting
Tell us what clinical phase your programme is in. We respond within 24-48 business hours.
Response within 24-48h
No obligation
Clinical roadmap in progress
Interactive simulator
👆 Click each phase to simulate how your roadmap would evolve
EMA scientific advice
Phase III endpoint alignment
Orphan drug designation
4Roadmap phases
1Scientific advice scheduled
1Team, entire roadmap
Illustrative example of a roadmap in clinical phase
A CRO you can trust
Direct, transparent communication at every stage, no middlemen and no fine print.
Budget adapted to your company
Flexible plans based on your company's size and stage of development.
A tailored regulatory plan
No generic templates: every roadmap is designed for your product and your context.
Step-by-step support
We guide you through every milestone along the way, not just the initial diagnosis.
How we work
From your current clinical data to EMA registration
01
Clinical programme assessment
We review the results of previous phases and your product's current regulatory status.
02
Regulatory roadmap adjustment
We redefine the regulatory pathway incorporating the clinical data already available.
03
EMA scientific advice
We prepare the key meetings before Phase III or registration decisions.
04
Support through to approval
Continuous follow-up through to the centralised procedure and authorisation.
What's included
The roadmap evolves with your clinical data, it doesn't stay fixed in an initial document
02
EMA scientific advice
Preparation of scientific advice meetings at key moments of clinical development.
03
Endpoint alignment
We validate efficacy criteria with the agency before committing to the Phase III design.
04
Special designations
Orphan drug, PRIME and other acceleration pathways when the clinical profile allows it.
05
Accelerated assessment
Eligibility assessment for accelerated assessment or conditional marketing authorisation with clinical data already generated.
06
Centralised procedure
Planning of the submission based on available clinical results.
We adapt to you
A plan tailored to your budget, not a fixed rate for everyone
Regulatory assessment
A first session to review your product and clinical data, and understand exactly what you need before committing budget.
Tailored roadmap
Full design of your regulatory strategy, adjusted to your development stage and your company's available budget.
Ongoing support
We support you through the roadmap execution, milestone by milestone, through to the centralised procedure and approval.
Why choose Geistek
The roadmap isn't set once — it's adjusted with every clinical milestone
Friction point
The roadmap isn't updated with new clinical data
The regulatory strategy stays frozen in the initial document, even as the programme moves forward.
Geistek solution
We adjust the strategy at every clinical milestone
We review and update the regulatory roadmap as results come in from each phase.
Friction point
Phase III decisions made without validating endpoints with the EMA
Pivotal designs get questioned later, once it's costly to fix them.
Geistek solution
We align endpoints before committing to the design
Scientific advice is raised right before the decisions that are hardest to reverse.
Friction point
Special designation options are lost by not anticipating them
Orphan drug or PRIME status stop being viable if not requested at the right time.
Geistek solution
We assess eligibility at every stage of development
We review which special designations remain viable as your programme progresses.
Our model
A partner integrated into your clinical and regulatory programme
One team, not a one-off report
We adjust the roadmap together with your clinical team at every phase, not just at the start of the programme.
01
Real experience with the EMA in clinical phase
Direct knowledge of how the conversation with the agency evolves as development progresses.
02
Coverage across Spain and the EU
Regulatory management with local presence and the ability to coordinate at a European level.
03
Connected to your clinical operations
The regulatory roadmap is adjusted alongside the operational management of your trials, not separately.
Coverage across Spain + the European Union
Regulatory strategy adjustment with the ability to coordinate across different member states when the clinical programme requires it.
Frequently asked questions
Common questions about this accompaniment
How does the regulatory roadmap change between Phase II and Phase III?
Phase II results reshape what the agency will accept as pivotal evidence, so the roadmap needs to be revisited before Phase III design is locked in — endpoints, population and statistical plan often need to be re-validated with the EMA at this point, not just carried over from the original plan.
When should we request EMA scientific advice on endpoints?
Right before the decisions that are hardest to reverse — typically before finalising the Phase III protocol. Raising it earlier usually means you don't yet have enough data to make the discussion useful; raising it later risks discovering a misalignment once the pivotal study is already running.
Can orphan drug designation still be requested during clinical phase?
Yes, as long as the prevalence and significant-benefit criteria are still supportable with the evidence available. We reassess eligibility at each phase, because a designation that wasn't viable preclinically can become viable once more clinical data exists — and vice versa.
What is the centralised procedure and when do we start preparing for it?
It's the EU-wide marketing authorisation route managed by the EMA, resulting in a single approval valid across all member states. Preparation should start well before Phase III completes — the dossier structure, evidence package and submission calendar all need to be planned while the pivotal data is still being generated, not after.
Let's start the conversation
Tell us what clinical phase your programme is in
We'll review your product's context and tell you, with no obligation, how we'd adjust your regulatory roadmap.
Request a meeting
We respond within 24-48 business hours.
Response within 24-48h
Plan adjusted to your budget
No obligation
