Summit Package

Full Submission Preparation & Delivery

When your program is ready to move from strategy into execution, the Summit Package provides complete, end-to-end submission development. From authoring and dossier assembly to CTIS/ESG navigation and authority correspondence, this package delivers a fully prepared, validated submission ready for regulatory review.

Designed for programs approaching their first IND, CTA, or EU CTR submission who need hands-on regulatory and operational support.

Who is this package for?

The Summit Package supports teams who are ready to build and deliver a complete regulatory submission. It is especially valuable for:

  • Sponsors preparing their first IND, CTA, or EU CTR Part I/II submission

  • Programs needing authoring, QC, formatting, and submission assembly

  • Teams unfamiliar with CTIS workflows, ESG requirements, or dossier publishing

  • Companies with limited internal bandwidth for full submission execution

  • Sponsors requiring support for RFI responses, follow-up clarifications, or Module 1 expectations

What you can expect?

A full-service submission experience that carries your program from preparation to successful delivery:

  1. Kickoff & Submission Planning
    Alignment on regulatory targets, timelines, study scope, and dossier expectations, including CTIS or IND structure.

  2. Module Authoring & Content Development
    Hands-on creation of regulatory elements such as Module 1, cover letters, forms, declarations, and submission-ready documentation.

  3. Document QC & Formatting
    Comprehensive review and formatting to ensure consistency, clarity, and compliance with region-specific requirements.

  4. Dossier Assembly & Publishing
    Complete compilation of the submission package, including eCTD/CTIS structure, file checks, hyperlinking, and technical validation.

  5. Submission Execution
    Delivery of the final, validated dossier through CTIS, ESG, or national agency portals, with confirmation of successful receipt.

  6. Post-Submission Support
    Assistance with RFI responses, clarification requests, authority follow-up, and ongoing communication until decision.

Why This Matters?

A well-built submission does more than meet regulatory requirements—it sets the tone for your relationship with authorities. The Summit Package ensures your IND, CTA, or EU CTR submission is organized, complete, and technically sound, reducing the risk of avoidable RFIs and accelerating review timelines

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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