Regulatory Guidance Built for Innovators

At ApexVera, we guide biotech and medtech teams through every stage of regulatory strategy and submission planning. Our service tiers help you move from early readiness to full execution with clarity, confidence, and expert support grounded in real-world EU and US experience.

Our Services

  • Foundation Package

    Regulatory Readiness Assessment
    A clear baseline review that confirms your program’s preparedness for EU regulatory engagement. Designed for early-stage teams who need to understand where they stand and what steps come next.

    You receive:
    • Gap assessment across clinical, CMC, and nonclinical areas
    • Readiness scoring with prioritized recommendations
    • Roadmap outlining next steps toward EU submission
    • Early guidance on CTIS planning, ODD/PIP feasibility, and RMS considerations

    Best for teams establishing their regulatory baseline and preparing for early EU strategy.

    Learn More

  • Ascent Package

    Strategic Submission Planning
    A focused strategy engagement that shapes your submission roadmap, Member State sequencing, and regulatory approach. Best for teams planning to submit within 6–12 months.

    You receive:
    • Regulatory pathway and submission model
    • CTIS vs IND timing and sequencing recommendations
    • Risk and dependency review with mitigation plan
    • Live strategy session plus summary deliverable

    Best for teams preparing to initiate their first regulatory submission

    Learn More

  • Summit Package

    Full Submission Preparation & Delivery
    Complete regulatory submission development and execution. Includes authoring, dossier assembly, publishing, and full support through authority review.

    You receive:
    • Full CTIS Part I/II or IND/CTA submission package build
    • Module 1 / Part I authoring, QC review, and formatting
    • Support for RFIs and authority questions
    • Final validated submission archive delivered to sponsor

    Best for teams approaching first submission and needing full execution support, not just guidance

    Learn More

Ongoing Regulatory Partnership

ApexVera offers a limited number of monthly regulatory partnership subscriptions for sponsors who require continuous regulatory support across programs and submissions. Each subscription is tailored to program needs and renews monthly.

Available exclusively to established clients.

Compass Support

Focused Regulatory Guidance

Compass Support provides rapid access to senior regulatory expertise for a single question, milestone, or deliverable. It’s designed for teams who need clear, timely direction without engaging in a full project or package.

You receive:
• Senior-level insight on a specific regulatory requirement or decision point
• Targeted review of documents or submission components
• Clear, actionable recommendations delivered efficiently
• Direction that helps you move forward with confidence

Best for teams needing immediate clarity on a focused regulatory question or task.

Request Support

Let’s Discuss Your Program

Whether you’re seeking regulatory strategy, submission execution, or EU CTR guidance, ApexVera partners with innovative teams to move programs forward with clarity and confidence.
Share a few details below and we’ll respond within one business day.