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Preclinical regulatory roadmap
Complete regulatory pathway defined from preclinical through to approval, with clear milestones and timelines.
Specialized consultancy · Your first contact with the EMA, well prepared
Your regulatory roadmap from preclinical stage, ready before your first EMA meeting
We define the complete regulatory pathway before you commit resources to clinical development: initial scientific advice, special designations and preparation of your first clinical trial application, with a tailored plan and step-by-step support.
Initial EMA scientific advice
Orphan drug designation
CMC and GLP review
Clinical trial application
Request a meeting
Tell us where your preclinical programme stands. We respond within 24-48 business hours.
Response within 24-48h
No obligation
Readiness check
Interactive checklist
👆 Tick what you already have sorted and discover what's missing
0/5
There is still work to do
This is how ready your programme is to talk to the EMA
Illustrative self-assessment — does not replace a real regulatory review
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 preclinical data to your first clinical trial
01
Preclinical assessment
We review your GLP data and quality profile (CMC) available to date.
02
Regulatory roadmap design
We define the full pathway from preclinical through to approval, with clear milestones.
03
Initial scientific advice
We prepare the first meeting with the EMA before committing to the clinical design.
04
Clinical trial application
Support in preparing and submitting your first clinical application.
What's included
Full regulatory preparation before your first clinical trial
02
Initial EMA scientific advice
Preparation and support for the first scientific advice meeting with the agency.
03
Special designations
Early eligibility assessment for orphan drug, PRIME and other acceleration pathways.
04
CMC and GLP review
Review of the quality profile and toxicology studies against EMA requirements.
05
Clinical trial application
Dossier preparation and support in submitting your first clinical application.
06
Transition to clinical phase
Direct connection with the clinical operations team so the roadmap doesn't break when you make the leap.
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 preclinical data, and understand exactly what you need before committing budget.
Tailored roadmap
Full design of your regulatory strategy from preclinical stage, adjusted to your company's available budget.
Ongoing support
We support you through the roadmap execution, milestone by milestone, through your first clinical trial and beyond.
Why choose Geistek
Where others improvise, we anticipate
Clinical development starts without a clear regulatory pathway
Development moves forward without knowing what the EMA will actually require, and surprises arrive once they're costly.
A complete roadmap before your first clinical trial
We design the regulatory pathway end to end before committing resources to development.
The first EMA meeting arrives unprepared
Initial scientific advice gets improvised, losing the chance to align expectations in time.
We prepare scientific advice with enough lead time
We arrive at the first EMA meeting with the strategy and documentation already worked through.
Special designation options are lost by not assessing them in time
Orphan drug or PRIME status stop being viable if not requested at the right time.
We assess eligibility from the preclinical stage
We review which special designations are viable before it's too late to request them.
Our model
A partner integrated from before your first clinical trial
One team, not a one-off report
We design the roadmap and support you through its execution, not just the initial diagnosis.
Real experience with the EMA
Direct knowledge of how the agency thinks and what it expects from the very first contact.
Coverage across Spain and the EU
Regulatory management with local presence and the ability to coordinate at a European level.
Strategy and execution together
The same team that designs the roadmap supports you until it becomes an approval.
Coverage across Spain + the European Union
Regulatory strategy design with the ability to coordinate across different member states when the programme requires it.
Frequently asked questions
Common questions about this accompaniment
What happens in an initial EMA scientific advice meeting?
You present your preclinical package and proposed clinical development plan to the agency and receive written feedback on your approach before you commit resources to the first clinical trial. Preparing the briefing document and rehearsing the discussion in advance is what makes that feedback actually useful.
When should we apply for orphan drug designation?
Ideally before the first clinical trial application, once there is enough preclinical and epidemiological evidence to support the prevalence and significant-benefit criteria. Applying too late can mean losing the incentives the designation provides.
Do you review our CMC and GLP data before the meeting?
Yes. We review the quality profile and toxicology package against EMA expectations to flag gaps early, so they can be addressed before the scientific advice meeting rather than surfacing as a surprise in the agency's questions.
What happens after the roadmap is defined?
We move into preparing the first clinical trial application, and the same regulatory strategy carries through into clinical-phase support and, later, EMA submission and accompaniment, so nothing has to be redesigned when your programme moves forward.
Let's start the conversation
Tell us where your preclinical programme stands
We'll review your product's context and tell you, with no obligation, how we'd design your regulatory roadmap.
Request a meeting
We respond within 24-48 business hours.
Response within 24-48h
Plan adjusted to your budget
No obligation
