Free guide + 2 annexes · For pharma & biotech teams

The Regulatory Submission Roadmap

The strategic view of your entire programme: what each phase triggers, how documents connect and when to act, from first-in-human to post-authorisation.

  • The full document landscape and how the CTD connects it
  • A phase-by-phase roadmap, from non-clinical to post-authorisation
  • Bonus: the 20 Key Documents Reference Tables, the Readiness Checklists and the Maturity Scorecard

Free · Sent by email · 3 PDFs

Sarah and Adrian Tilly

Written by Sarah & Adrian Tilly
Co-founders, Azur Health Science
The Regulatory Submission Roadmap – guide and 2 annexes
The Regulatory Submission Roadmap – cover
250+
projects delivered
FDA & EMA
submissions & approvals
20
medical writing & regulatory experts
Since 2017
supporting life sciences teams

200+ documents, many teams, one programme.
Without a clear strategy, it’s easy to get lost.

No shared roadmap

Dozens of interdependent documents, produced by sponsors, CROs and internal teams across regions, with no end-to-end framework to orchestrate them.

Writers brought in too late

Medical writing starts after data lock, so documents are drafted reactively, in isolation and under extreme time pressure.

Handovers that leak quality

Poorly structured CRO–sponsor–writer handovers cause inconsistent messaging, duplicated effort and version-control failures.

The result: avoidable agency questions, submission delays and postponed patient access, while leadership waits for timelines and budgets nobody can give with confidence.

What’s inside the guide

Six parts, from strategy to a self-assessment you can run with your team.

  1. 1
    Why Strategic Medical Writing Changes Everything
    Document factory vs strategic partner, and the real cost of late engagement.
  2. 2
    The Regulatory Document Landscape
    5 document families, the CTD architecture and the agency clocks.
  3. 3
    Phase by Phase: The Medical Writing Roadmap
    What each stage triggers, and how parallel writing can bring a submission forward from 12–18 to 5–8 months after data lock.
  1. 4
    Working with Teams, CROs and Agencies
    A sponsor–CRO–writer matrix and a 5-step method to answer agency questions.
  2. 5
    The Azur Health Science Approach
    Audit, strategy, production, review and submission support.
  3. 6
    Maturity Scorecard
    Rate your organisation on 15 statements.

3 resources, one download

Everything you need to plan your next submission, and keep at hand on every project.

The Regulatory Submission Roadmap – guide cover
Guide · 15 pages

The Regulatory Submission Roadmap

The end-to-end strategic view, phase by phase, from first-in-human to post-authorisation.

Annex A – Regulatory Reference Tables – cover
Annex A · 13 pages

Regulatory Reference Tables

The 20 Key Documents Reference Tables (purpose, regulatory anchor, common pitfalls), plus documents by pathway, EMA & FDA clocks, UK routes, scientific advice milestones and stage-by-stage detail.

Annex B – Regulatory Toolkit – cover
Annex B · 8 pages

Regulatory Toolkit

The Maturity Scorecard, the Readiness Checklists by phase, the Glossary and the Abbreviations.

Sneak peek

Where does your programme stand on the roadmap?

See every key document and scientific advice milestone, stage by stage, from discovery to post-authorisation.

The phase-by-phase regulatory roadmap – preview

What changes for your team

Without the roadmap
With the roadmap
Visibility
✕
No clear view of which documents are needed, when and by whom.
✓
A complete end-to-end roadmap: every document, milestone and handover, from first-in-human to post-authorisation.
Medical writing
✕
Engaged late, as a document production service.
✓
Integrated early, as a strategic partner.
Scientific story
✕
Each document drafted in isolation, with inconsistent messaging.
✓
One consistent benefit-risk story, from the IB to the SmPC.
Agency review
✕
Avoidable agency questions and costly revision cycles.
✓
Fewer agency questions and a faster review.
Your team
✕
Working from different assumptions, in firefighting mode.
✓
Working from the same framework and vocabulary.
Visibility
✕ No clear view of which documents are needed, when and by whom.
✓ A complete end-to-end roadmap: every document, milestone and handover, from first-in-human to post-authorisation.
Medical writing
✕ Engaged late, as a document production service.
✓ Integrated early, as a strategic partner.
Scientific story
✕ Each document drafted in isolation, with inconsistent messaging.
✓ One consistent benefit-risk story, from the IB to the SmPC.
Agency review
✕ Avoidable agency questions and costly revision cycles.
✓ Fewer agency questions and a faster review.
Your team
✕ Working from different assumptions, in firefighting mode.
✓ Working from the same framework and vocabulary.

What you will be able to do

  • Understand every regulatory document across the lifecycle and how they connect
  • Brief senior leadership on timelines, budget and risk with confidence
  • Anticipate each phase’s documents before they become urgent
  • Engage writers early enough to add strategic value
  • Plan handovers that don’t leak quality
  • Present one consistent benefit-risk narrative across the dossier

Built for the leaders who carry the regulatory load

Heads of Regulatory Affairs

Align teams and brief senior management or investors.

CMOs & R&D Directors

Make the right resourcing and outsourcing calls.

Medical Writing Managers

Move your function from production to strategy.

Project Managers & CRO partners

Plan timelines and handovers across the programme.

Sarah and Adrian Tilly

About the authors

Sarah & Adrian Tilly

Co-founders of Azur Health Science

Sarah and Adrian founded Azur Health Science in 2017. With deep experience across global submissions and strategic regulatory initiatives, from oncology and rare disease to medical devices and paediatrics, they combine complementary strengths: Sarah brings an international perspective shaped by her leadership within EMWA, while Adrian safeguards scientific rigour and quality standards. Together, they lead large multi-author teams and mentor the next generation of writers.

“Sarah rapidly became central to the global team responsible for the European MAA and was very quick and accurate and used her extensive knowledge of registration dossiers to add value in several areas of the submission.”

Head of European Clinical Development
European MAA submission

Get your free roadmap

A 15-page guide + 2 annexes. 30 minutes to read, a reference for every phase of your programme.

Free · Sent by email · 3 PDFs

Planning your next submission?

The Azur Health Science team

Our regulatory experts and medical writers can audit your documentation, build your writing strategy and support you through submission and agency questions.

Frequently asked questions

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

Three PDFs: the 15-page guide, Annex A – Regulatory Reference Tables (13 pages) and Annex B – Regulatory Toolkit (8 pages).

Regulatory affairs, medical writing, clinical and project teams in pharma, biotech and CROs who plan or contribute to regulatory submissions.

Yes. It covers EMA, FDA and UK (MHRA) pathways, agency clocks and scientific advice milestones.

No. We will only email you when new resources are available. You can unsubscribe at any time via the link in each message.

Yes. We support you at every stage, with both regulatory strategy and medical writing. Book a call →