Free guide + checklist · For pharma & biotech teams

The Kick-Off Meeting Guide for Regulatory Projects

Turn your kick-off meeting from a formality into real alignment: clear roles, a defined scope, dated review windows and fewer rewrites.

  • Prepare, conduct, follow up: the 3 steps of an effective KOM
  • 5 lessons from experienced project teams and the tools to set up
  • Bonus: the Pre-KOM Checklist, 19 questions to answer before your next KOM

Free · Sent by email · 2 PDFs

Jane LohRose-Laurence Gallay
Written by Jane Loh & Rose-Laurence Gallay
Senior Medical Writer & Lead Business Developer, Azur Health Science
The Kick-Off Meeting Guide for Regulatory Projects and the Pre-KOM Checklist
The Kick-Off Meeting Guide for Regulatory Projects – cover
250+
projects delivered
FDA & EMA
submissions & approvals
20
medical writing & regulatory experts
Since 2017
supporting life sciences teams

You already hold a kick-off meeting.
The hard part is leaving it truly aligned.

Roles assumed, not assigned

Nobody confirms who decides, who reviews and who consolidates comments.

Review windows without dates

Timelines feel reasonable in the meeting, but nothing makes them stick.

Scope that grows quietly

New documents and requests are absorbed informally, without a clear decision.

The result: a false sense of alignment that unravels slowly and expensively, with longer review cycles, slipped timelines and rework at Draft 2.

What’s inside the guide

Seven practical parts, from preparation to a ready-to-use checklist.

  1. 1
    Why the Kick-Off Meeting Matters
    The decisions that quietly derail projects later.
  2. 2
    Prepare Before the Meeting
    Foundation, inputs, governance and risks to clarify first.
  3. 3
    Conduct the KOM
    Six topics to discuss and agree on, in order.
  4. 4
    Follow Up After the KOM
    Summary, action items and a single source of truth.
  1. 5
    Five Lessons from Experienced Project Teams
    The habits that keep projects on track.
  2. 6
    Practical Tools to Set Up
    Agenda, summary template, trackers and governance matrix.
  3. 7
    The Pre-KOM Checklist
    19 questions to answer before your next KOM.

2 resources, one download

Everything you need to set up your next kick-off, and to reuse on every project.

The Kick-Off Meeting Guide for Regulatory Projects – guide cover
Guide · 14 pages

The Kick-Off Meeting Guide for Regulatory Projects

How to prepare, conduct and follow up on your KOM, with five lessons from experienced teams and the tools to set up.

The Pre-KOM Checklist – cover
Checklist · 4 pages

The Pre-KOM Checklist

19 questions to answer before your next KOM, as a stand-alone PDF ready to share with your team.

Sneak peek

Is your next kick-off meeting ready?

Check the first 3 questions now. 16 more are waiting in the guide and the Pre-KOM Checklist.

The Pre-KOM Checklist – preview of the first questions

What changes for your team

Without the guide
With the guide
Roles
✕
Assumed, not assigned.
✓
Roles and decision authority confirmed from day one.
Review windows
✕
Approximate durations that slip.
✓
Set as calendar dates, not durations.
Scope
✕
Expands informally, request by request.
✓
Documented; any addition is a conscious decision.
Drafts
✕
Settled discussions reopen at Draft 2.
✓
Draft 1 aligned; later drafts refine rather than redirect.
Roles
✕ Assumed, not assigned.
✓ Roles and decision authority confirmed from day one.
Review windows
✕ Approximate durations that slip.
✓ Set as calendar dates, not durations.
Scope
✕ Expands informally, request by request.
✓ Documented; any addition is a conscious decision.
Drafts
✕ Settled discussions reopen at Draft 2.
✓ Draft 1 aligned; later drafts refine rather than redirect.

What you will be able to do

  • Know exactly what must be decided by the end of the meeting
  • Confirm roles and decision authority from the start
  • Lock review windows to calendar dates, not vague durations
  • Agree what’s in scope (and what’s out) before drafting begins
  • Surface project risks early, while they’re still cheap to fix
  • Leave with Draft 1 aligned

Built for the leaders who commission regulatory documents

Heads of Regulatory Affairs

Accountable for timelines, budget and governance.

In-house Medical Writing Managers

Set outsourced projects up to run smoothly from day one.

CMOs & senior clinical leaders

Avoid absorbing the cost when kick-offs go wrong.

Project & study leads

Commissioning CSRs, manuscripts, RWE reports or CTDAPs.

Jane Loh

About the authors

Jane Loh

Senior Medical Writer

Epidemiologist and regulatory medical writer with an MSc in Population & Public Health. She works end-to-end on clinical programmes with complex data and small populations, from study design and data interpretation to publication-ready writing.

Rose-Laurence Gallay

Rose-Laurence Gallay

Lead Business Developer

Lead Business Developer at Azur Health Science, Rose connects pharma, biotech and CRO partners with the medical writing and consulting expertise they need, building long-term partnerships across Europe and international markets.

“It is always a pleasure to work with Azur. [You] always produce high quality documents, within timelines and always with open communication and constant feedback.”

Head of Medical Writing Department
CRO

Get your free guide

A 14-page guide + the 4-page Pre-KOM Checklist. 15 minutes to read, a framework for every kick-off.

Free · Sent by email · 2 PDFs

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Frequently asked questions

Yes. Just leave your email address and you will receive the guide and the checklist by email.

Two PDFs: the 14-page guide, about 15 minutes to read, and the Pre-KOM Checklist (4 pages), to use before every kick-off meeting.

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