Regulatory Guidance Built for Innovators

ApexVera supports U.S.-based biotech companies and CROs as they plan and execute EU regulatory strategy. From early readiness through CTIS submission and authority interaction, our guidance is practical, hands-on, and grounded in real-world EU experience.

EU Regulatory Strategy, Built for Execution

Work is scoped to your program stage and what you actually need now.

  • Regulatory Readiness Assessment

    Confirm where your program truly stands before you move into the EU. We take a practical look at what’s ready, what isn’t, and what needs attention so there are no surprises later.

    You’ll receive:
    • A focused review across clinical, CMC, and operational readiness
    • Clear priorities and risk flags
    • A simple, step-by-step roadmap for what to tackle next

    Best for teams establishing their EU foundation before their first submission

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  • Strategic Submission Planning

    Before committing time and budget, we work through the strategy together. We map the right EU pathway, talk through sequencing, and align on a CTIS approach that fits your program and your team.

    You’ll receive:
    • A clear regulatory pathway and submission model
    • RMS and Member State strategy grounded in real-world experience
    • Practical timing, sequencing, and dependency planning

    Best for teams preparing for their first EU submission

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  • Full Submission Support

    When it’s time to submit, we stay close to the work. From planning through authority review, we lead the coordination, keep the dossier moving, and make sure nothing falls through the cracks.

    You’ll receive:
    • Dossier coordination and hands-on build support
    • Part I/II or IND/CTA readiness and execution guidance
    • RFI planning and direct authority response support

    Best for teams that need execution support, not just advice

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Ongoing Regulatory Partnership

ApexVera offers a limited number of ongoing regulatory partnerships for sponsors who need consistent, senior-level EU regulatory support across programs and submissions. These partnerships are structured around program needs and reviewed on a monthly basis.

Available to existing clients following an initial engagement.

Compass Support

On-Demand Senior Regulatory Support

Sometimes you don’t need a full submission or a large project. You just need an experienced voice to sense-check a plan, review a document, or talk through a decision.

Compass Support gives you direct access to senior EU regulatory guidance when questions come up and you need clarity quickly.

You’ll receive:
• Senior-level input on specific regulatory questions or decisions
• Targeted review of documents or submission components
• Clear, practical recommendations aligned to EU expectations
• Straightforward next steps so you can move forward with confidence

Best for teams who need fast, focused EU regulatory support without starting a full project

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Let’s Discuss Your Program

ApexVera works with biotech companies and CROs to execute EU regulatory strategy with clarity. From readiness through CTIS submission and authority interaction, our guidance is practical, focused, and grounded in real-world EU experience.