Azur Academy

Regulatory & medical writing expertise, free for life sciences leaders

Practical guides, checklists and frameworks, written by the medical writers and regulatory experts behind 250+ projects.

  • Built from real FDA & EMA project experience
  • Ready-to-use tools, not theory
  • Free, for pharma, biotech and CDMO decision-makers
Azur Academy resources: free guides, checklists and frameworks for life sciences leaders
250+
projects delivered
FDA & EMA
submissions & approvals
20
medical writing & regulatory experts
Since 2017
supporting life sciences teams

Choose your resource

Five practical resources, each written by an Azur Health Science expert from real project experience.

The Regulatory Submission Roadmap – guide and 2 annexes
Latest resource · Guide + 2 annexes

The Regulatory Submission Roadmap

A full programme generates 200+ interdependent documents. This guide and its 2 annexes map every document and milestone from first-in-human to post-authorisation, so you plan with a clear strategy.

  • The document landscape and the CTD architecture
  • A phase-by-phase roadmap and the Readiness Checklists
  • The Maturity Scorecard for your writing function
Sarah and Adrian Tilly

By Sarah & Adrian Tilly
Co-founders
Best Review Practices for Regulatory Documents

Best Review Practices for Regulatory Documents

One draft, many reviewers, conflicting comments. This guide turns document review into a quality accelerator: 7 principles, a 5-stage review model and ready-to-use checklists.
  • 7 principles of effective review
  • The 5-stage review model, from planning to approval
  • A reviewer matrix and 4 ready-to-use checklists
Socrates Lopez Noguerola, PhD

By Socrates Lopez Noguerola, PhD
Medical Writer
The Kick-Off Meeting Guide for Regulatory Projects and the Pre-KOM Checklist

The Kick-Off Meeting Guide for Regulatory Projects

Most project delays start before the first draft. This guide and its checklist help you prepare, run and follow up on kick-offs that align roles, scope and reviews from day one.
  • The 3 steps: prepare, conduct, follow up
  • 5 lessons from experienced project teams
  • The Pre-KOM Checklist (19 questions)
Jane LohRose-Laurence Gallay
By Jane Loh & Rose-Laurence Gallay
Senior Medical Writer & Lead Business Developer
The White Paper Guide for Life Sciences

The White Paper Guide for Life Sciences

You have the science. This guide shows you how to turn it into White Papers that build authority and generate qualified leads: 7 steps, the 8-part anatomy and a 12-point checklist.
  • 7 steps to an effective White Paper
  • The 8-part anatomy, section by section
  • The 12-point checklist before you publish
Yasmina Curto

By Yasmina Curto, PhD
Medical Writer
Innovative Trial Designs in Rare Diseases – coming soon
Coming soon · Guide

Innovative Trial Designs in Rare Diseases

In rare diseases, patients are a finite resource. This upcoming guide compares the adaptive and master protocol designs that make the most of them, and what FDA and EMA expect.
  • Five adaptive designs, from dose to endpoints
  • Basket, umbrella and platform master protocols
  • FDA, EMA and ICH E20 expectations
Peter Morgan

By Peter Morgan, PhD
Senior Medical Writer

Which resource fits your challenge?

Your challenge The resource
Mapping the documents and milestones of a full clinical programme The Regulatory Submission Roadmap →
Review cycles that drag on and produce conflicting comments Best Review Practices →
Designing a trial for a small, scattered patient population Innovative Trial Designs in Rare Diseases (coming soon) →
Starting a writing project without real alignment The Kick-Off Meeting Guide →
Turning your science into content that builds authority The White Paper Guide for Life Sciences →
Mapping the documents and milestones of a full clinical programme
→ The Regulatory Submission Roadmap
Review cycles that drag on and produce conflicting comments
→ Best Review Practices
Designing a trial for a small, scattered patient population
→ Innovative Trial Designs in Rare Diseases (coming soon)
Starting a writing project without real alignment
→ The Kick-Off Meeting Guide
Turning your science into content that builds authority
→ The White Paper Guide for Life Sciences

Written by the experts who do the work

Every resource comes from the medical writers and regulatory experts who deliver our client projects.

Sarah and Adrian Tilly
Sarah & Adrian Tilly
Co-founders of Azur Health Science
The Regulatory Submission Roadmap
Socrates Lopez Noguerola, PhD
Socrates Lopez Noguerola, PhD
Medical writer, PhD in Neuroscience
Best Review Practices
Peter Morgan
Peter Morgan, PhD
Senior medical writer, PhD in neural stem cell research
Innovative Trial Designs in Rare Diseases (coming soon)
Jane LohRose-Laurence Gallay
Jane Loh & Rose-Laurence Gallay
Senior medical writer & epidemiologist · Lead Business Developer
The Kick-Off Meeting Guide
Yasmina Curto
Yasmina Curto, PhD
Medical writer, PhD in Neuroscience
The White Paper Guide

Built for the leaders who carry the regulatory load

Heads of Regulatory Affairs

Align teams, timelines and submissions across regions.

Medical Writing Managers

Standardise quality across writers, reviewers and agencies.

CMOs & clinical leaders

Protect scientific integrity and a consistent benefit-risk story.

Biotech & CDMO leaders

Make the right calls on design, resourcing and outsourcing.

What our clients say

“
Azur Health Science is a very competent medical writing partner. We have appreciated your professionalism in terms of both the editorial and the coordinating work, including division of responsibilities and delivery of results towards a tight timeline.
Communications & Content Officer
EU-funded Research Infrastructure
“
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
“
Thanks for all your work on this! You made it relatively simple for the rest of us. Much appreciated.
Senior VP Global Regulatory Affairs
Pharma
Beyond the resources

Need expert support on your next project?

The Azur Health Science team
The experts behind these resources support pharma, biotech and CDMO teams every day, across regulatory, clinical trials, scientific communication and project management.
✓

Regulatory strategy & submission documents

✓

Clinical trial protocols & reports

✓

Scientific communication, including White Papers

Frequently asked questions

Yes. Open the resource page and leave your email address to receive it.

Azur Health Science medical writers and regulatory experts, based on their project experience with FDA and EMA submissions.

PDF resources. Most come as a pack: a guide plus a summary, checklist, infographic or annex you can use straight away.

CMOs, Heads of Regulatory Affairs, Medical Writing Managers and biotech & CDMO leaders who need to plan, commission or review regulatory and scientific documents.

Yes. From regulatory strategy to writing, review and submission. Book a call →