Medical Writing, your way

At Azur Health Science, we integrate smoothly with your internal teams. With our ethos of valuing individuals and respecting the team, we help expedite the delivery of your medical writing projects in harmony with your internal setup.

From protocols and clinical study reports to submissions, regulatory responses, postmarketing studies, publications, presentations, and creative output, we will help you create targeted documents and content upstream and maximise your workflow, bringing value at every point of the clinical and commercial lifecycle of your product.

Whatever we are working on, we try to remember that we are writing for patients, people with a family, a career, with hope for the future.

Working as a Team, writing for patients

What we write

Whatever the task, we never forget that we are writing for the benefit of patients: people with families, careers, and hope for the future.

Regulatory (study-level)

  • Clinical study protocols
  • Protocol amendments
  • Clinical investigation plans (CIPs)

  • Patient information
  • Investigator brochures (IBs)
  • General investigation plans
  • Clinical study reports (CSRs)
  • CSR addendums
  • Clinical evaluation reports (CERs)

  • Patient narratives
  • Plain langauge summaries
  • Post-authorisation studies

Regulatory (submissions)

  • Clinical overviews (M 2.5)
  • Clinical summaries (M2.7.1/.2/.3./4)
  • Risk management plans (RMPs)/ Risk evaluation and mitigation strategies (REMS)
  • Regulatory responses
  • Responses to written requests
  • Rest of world submissions
  • Orphan drug designation requests and maintainance reports
  • Pediatric study plans and modifications (PIPs/PSPs)

  • Requests for accelerated assessment of marketing applications
  • Integrated summaries (ISS, ISE, ISI)
  • Briefing documents and other scientific advice
  • Periodic safety update reports (PSUR)
  • Periodic benefit-risk evaluation reports (PBRER)
  • Annual reasessments
  • Variations and supplements

Medical Communications

  • Original articles
  • Systematic reviews
  • Slide decks
  • Response to media questions
  • Training slides

  • Plain language scientific reports, reviews and visuals

  • Online training management
  • Scientific posters
  • Podcasts

  • Webinars

  • Blog posts
  • Website content
  • Infographic design
  • Visual facilitation

Quality Control

In parallel with our writing services, at Azur Health Science we offer the possibility of providing an expert, independent quality control check (QC) of your documents.

This can include:

  • Content QC
  • Copy editing
  • Formatting
  • Compliance with style guides
  • Publishing-ready checks

QC checks are usually carried out when the document is at the finalisation stage.

Some of our publications

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    Introducing EMWA’s new AI Working Group

    21/10/2023
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    Bridging the gap: Academia to industry.

    24/02/2023
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    One size doesn’t fit all: Tailored medical writing mentoring and training.

    24/02/2023
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    Protection of neurons derived from human neural progenitor cells by veratridine.

    24/02/2023
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    Flu, Season, Diseases Affect Trials

    24/02/2023
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    Human neural progenitor cells show functional neuronal differentiation and regional preference after engraftment onto hippocampal slice cultures

    24/02/2023
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    Spontaneous calcium transients in human neural progenitor cells mediated by transient receptor potential channels.

    24/02/2023
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    A Randomized, Controlled Trial of Oral Propranolol in Infantile Hemangioma

    24/02/2023
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    Safety of Oral Propranolol for the Treatment of Infantile Hemangioma: A Systematic Review.

    24/02/2023
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    Inhibition of primary breast tumor growth and metastasis using a neuropilin-1 transmembrane domain interfering peptide.

    24/02/2023
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    Functionalized Tobacco Mosaic Virus Coat Protein Monomers and Oligomers as Nanocarriers for Anti-Cancer Peptides

    21/02/2023
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    Kv1.1 contributes to a rapid homeostatic plasticity of intrinsic excitability in CA1 pyramidal neurons in vivo

    21/02/2023
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    G protein-coupling of adhesion GPCRs ADGRE2/EMR2 and ADGRE5/CD97, and activation of G protein signalling by an anti-EMR2 antibody

    21/02/2023