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 White Paper Guide for Life Sciences
Latest resource

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
Strategic Overview Masterclass

Strategic Overview Masterclass

A submission is dozens of interdependent documents. This masterclass maps an actionable end-to-end roadmap, from first-in-human to post-authorisation, so you can brief leadership and plan every handover.
  • The complete document landscape across the lifecycle
  • A phase-by-phase medical writing roadmap
  • A document-readiness checklist and glossary
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
Rare Disease Protocols

Rare Disease Protocols

Small, scattered populations make traditional trials unworkable. Compare adaptive and master protocol designs (basket, umbrella, platform) and choose one that holds up under FDA and EMA scrutiny.
  • Adaptive randomisation and dose-group designs
  • Basket, umbrella and platform master protocols
  • FDA, EMA and CTFG guidance at a glance
Peter Morgan

By Peter Morgan, PhD
Senior Medical Writer
The Kick-off Meeting Checklist

The Kick-off Meeting Checklist

Most project delays start at the kick-off. This checklist turns your kick-off meeting into real alignment on roles, scope, data, timelines and risks, so you leave with Draft 1 aligned.
  • A pre-KOM prep checklist
  • The KOM agenda: roles, scope, data, timelines, risks
  • A 20-question readiness assessment
Jane LohRose Gallay-Menil
By Jane Loh & Rose Gallay-Menil
Senior Medical Writer & Business Development Lead

Which resource fits your challenge?

Your challenge The resource
Mapping the documents and milestones of a full clinical programme Strategic Overview Masterclass →
Review cycles that drag on and produce conflicting comments Best Review Practices →
Designing a trial for a small, scattered patient population Rare Disease Protocols →
Starting a writing project without real alignment The Kick-off Meeting Checklist →
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
→ Strategic Overview Masterclass
Review cycles that drag on and produce conflicting comments
→ Best Review Practices
Designing a trial for a small, scattered patient population
→ Rare Disease Protocols
Starting a writing project without real alignment
→ The Kick-off Meeting Checklist
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
Strategic Overview Masterclass
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
Rare Disease Protocols
Jane LohRose Gallay-Menil
Jane Loh & Rose Gallay-Menil
Senior medical writer & epidemiologist · Business Development Lead
The Kick-off Meeting Checklist
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 →