Compass Support

Focused Regulatory Guidance

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

Who is this for?

This option is ideal for teams seeking quick clarity on a targeted regulatory issue, document, or decision point.

Who is this support for?

Compass Support is especially valuable for:

• Sponsors needing immediate clarity on a specific regulatory question

• Teams preparing or refining a single submission component

• Companies requiring early insight before committing to a larger initiative

• Programs evaluating pathways, timelines, or development options

What you can expect?

A concise, expert-driven engagement designed to deliver actionable direction:

Targeted Question Review – Senior-level insight on a specific regulatory requirement or decision point.

Document or Data Evaluation – Focused review of your materials with clear feedback and recommendations.

Actionable Guidance – Practical, concise next steps delivered quickly to maintain progress.

Short-Term Follow-Up – Brief email support to resolve clarifications or refine your direction.

Why this matters?

Timely, expert input helps teams make informed decisions, resolve bottlenecks, and maintain development momentum. Compass Support gives you the clarity you need—exactly when you need it.

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.