Full Submission Support
Before moving into an EU submission, it helps to step back and set the strategy first. Pathway decisions, Member State selection, and timing choices made early can have a big impact later.
We work through the plan together so you know exactly where you’re going, what order things should happen in, and how to approach CTIS with fewer surprises.
When teams use this
• Preparing for an EU CTR or CTA submission
• Managing Part I and Part II documents across teams
• Needing hands on regulatory coordination and oversight
• Working against tight timelines
• Wanting experienced support during authority questions or RFIs
What the process looks like
Planning and kickoff
We align on scope, timelines, and responsibilities so everyone knows what needs to happen and when.
Dossier coordination
I help organize documents, track readiness, and keep clinical, CMC, and operational inputs moving in sync.
Submission preparation
Part I and Part II content is reviewed for completeness, consistency, and EU expectations before submission.
CTIS execution
Support through the mechanics of submission, tracking, and communication during review.
Authority questions and RFIs
Practical support drafting responses and coordinating updates so the process stays on track.
Follow up support
Continued guidance through early post submission activities as needed.
Why this matters
Submissions often slow down not because of science, but because of coordination gaps and last minute surprises. Having steady regulatory leadership in place helps keep timelines realistic and reduces rework.
It allows your team to focus on the program while the submission process stays organized.
Why ApexVera
You work directly with me. No handoffs. No layers.
I’ve led EU CTR submissions and CTIS workflows and worked through real authority questions. The guidance is practical and based on what actually happens, not theory.
Next steps
If you'd like to talk through your program and see whether a readiness review makes sense, we can start with a short call.