Ascent Package

Strategic Submission Planning

Teams preparing for their first IND, CTA, or EU CTR submission often need a clear strategy—one that aligns data, timing, sequencing, and regulatory expectations across markets. The Ascent Package provides focused, senior-level guidance to shape your submission roadmap and position your program for regulatory success.

This package is designed for programs within 6–12 months of submission that need defined regulatory pathways, Member State strategy, and coordinated US/EU planning.

Who is this package for?

The Ascent Package supports teams that are preparing to move from planning into execution. It is especially valuable for:

  • Sponsors approaching their first IND, CTA, or EU CTR submission

  • Programs needing clarity on CTIS timelines, RMS selection, or Member State sequencing

  • Teams preparing for IND/CTA alignment across the US and EU

  • Companies with multiple development tracks who need integrated regulatory strategy

  • Programs transitioning from nonclinical to clinical who require structured submission planning

What you can expect?

A structured, collaborative experience that gives you a complete regulatory strategy:

  1. Strategic Intake Session
    A focused meeting to understand your program, study design, development history, and intended regulatory pathway.

  2. Document & Data Review
    Review of your current preclinical, CMC, and clinical planning materials to identify gaps, risks, and regulatory considerations.

  3. Submission Strategy Development
    A written regulatory strategy covering pathways, timelines, Member State considerations, CTIS expectations, and IND/CTA alignment.

  4. Risk & Dependency Mapping
    Identification of sequencing risks, required data dependencies, and mitigation recommendations to keep development on track.

  5. Live Strategy Review
    A final discussion to walk through your customized plan and align stakeholders on timelines, priorities, and next steps.

Why This Matters?

Clear submission strategy reduces uncertainty, strengthens cross-functional alignment, and ensures your team enters regulatory engagement prepared and confident. The Ascent Package equips you with a defined pathway, realistic timelines, and actionable recommendations based on real-world regulatory experience.

Next Step

Why ApexVera?

ApexVera brings hands-on experience with EU CTR submissions, IND planning, CTIS strategy, Member State coordination, IRIS, ODD, PIP preparation, and regulatory sequencing across the US and EU. The approach is practical, data-aware, and tailored to the needs of clinical-stage and near-submission biotech teams—providing clarity without unnecessary complexity.

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