Foundation Package

Regulatory Readiness Assessment

Early-stage teams often know their science—but need clarity on regulatory expectations, timing, and next steps. The Foundation Package delivers a focused assessment of your program with a written roadmap tailored to your development stage.

This is the ideal starting point for companies entering EU or US regulatory pathways for the first time.

Who is this package for?

This package supports teams that need regulatory clarity before moving forward. It is especially useful for:

  • Founders preparing their first IND or CTA

  • Teams needing alignment on EU CTR expectations and RMS strategy

  • Companies unsure whether their data package is ready for regulatory engagement

  • Programs entering early clinical development that require a structured regulatory plan

What you can expect?

A clear, streamlined experience from start to finish:

1. Introductory Call
A short intake meeting to understand your program, target markets, and development goals.

2. Document Review
Assessment of your scientific data, preclinical package, and current regulatory considerations.

3. Tailored Roadmap
A written regulatory plan outlining pathways, next steps, timelines, and key requirements.

4. Short-Term Email Support
A brief support period after delivery to address clarifications or refine next steps.

Why This Matters?

Early regulatory clarity helps teams avoid delays, set realistic timelines, and prepare for future interactions with FDA, EMA, and national authorities. The Foundation Package gives you that clarity before you invest in larger programs or submissions.

Next Step

Why ApexVera?

ApexVera brings hands-on experience with EU CTR submissions, CTIS navigation, IRIS, ODD, PIP strategy, and IND/CTA alignment across the US and EU. With a focus on early-stage biotech programs, the approach is practical, efficient, and designed to provide clear next steps without unnecessary complexity.

Schedule Intro Call