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Continuous EMA Accompaniment
One team managing your regulatory execution from the first filing through to approval, with no handoffs along the way.
Continuous EMA accompaniment, one team throughout
Regulatory execution and EMA accompaniment, without handoffs or gaps
Continuous submission and agency interaction support — the same team from your first filing through to approval, so nothing gets lost between people who don't know your project.
Continuous EMA Accompaniment
No Handoffs
Submission Support
Single Point of Contact
Continuity Tracker
Interactive overview
👆 Click each milestone — same team, every time
Handled by your Geistek team
Submission preparation
We assemble and quality-check the filing before it goes to the agency — the same specialists who will handle every question that comes back.
Illustrative overview of a typical submission cycle
A CRO You Can Trust
Direct, transparent communication at every stage — no middlemen, no fine print.
Budget Adapted to Your Company
Flexible plans based on your company's size and stage of development.
A Plan Built Around Your Program
No generic templates — every engagement is scoped for your specific project.
One Team, Start to Finish
The same specialists accompany your project from filing through to approval.
How We Work
Continuous accompaniment, from filing to approval
01
Regulatory Execution Assessment
We review your current submission status and where continuous support would add the most value.
02
Submission Preparation & Filing
We assemble, quality-check, and file your submission with the agency.
03
Continuous Agency Interaction
We manage every question and follow-up round, with the same team that filed the original submission.
04
Accompaniment Through Approval
We stay with your project until approval is secured — not just until the first submission is sent.
What's Included
Continuous execution support, not a one-time filing service
02
Submission Preparation & Filing
Assembly and quality control of your regulatory submissions before they reach the agency.
03
Agency Q&A Management
Structured handling of every question round from the agency, without losing context between rounds.
04
Amendment & Variation Support
Ongoing support for amendments and variations as your program evolves after initial filing.
05
Timeline & Milestone Tracking
Clear visibility into where your submission stands and what's coming next, at every stage.
06
Single Point of Contact
One team you can reach directly, instead of being routed between different consultants.
Why Choose Geistek
Execution shouldn't restart every time someone new picks up your file
Projects get passed between different consultants mid-process
Every handoff means re-explaining context, and details get lost along the way.
One team stays with your project from filing to approval
The people who prepared your submission are the same people who answer for it.
Agency questions arrive and nobody available understands the full history
Delays pile up while someone gets up to speed on a file they didn't prepare.
Continuous accompaniment means we already know your file
Every follow-up question is answered by someone who was there from the start.
Submission timelines slip because of internal handoffs
Time gets lost in translation between the people who filed and the people who follow up.
No handoffs means no lost time between people
One continuous thread of accountability, from filing to approval.
Our Model
One team, accountable from filing to approval
01
Real Experience with the EMA
Direct knowledge of how the conversation with the agency evolves round after round.
02
No Handoffs, No Gaps
The same specialists stay accountable for your project from start to finish.
03
Budget Adapted to Your Project
Flexible plans based on your program's size and the level of accompaniment you need.
Let's Start the Conversation
Tell us where your submission stands today
We'll review your project's context and tell you, with no obligation, how continuous accompaniment would fit into your process.
Request a Consultation
We typically respond within 24-48 business hours.
Response within 24-48h
No obligation
Confidential by default
