Regulatory Medical Writing

Regulatory and Creative Medical Writing Services for the Pharmaceutical & Biotechnology Industries

Mentoring for Aspiring Medical Writers

Our philosophy

At Azur Health Science, specialist in regulatory medical writing we believe that every individual matters, that every patient should be valued as a person and that we have a responsibility to inspire and motivate others.

When these values become a reality, we write with passion, communicate with understanding and strive for excellence. Our team will assist you with your regulatory writing requirements.

Medical writing, your way

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.

Medical writing is of particular importance, as it guarantees the validity and credibility of the information exchanged.

Our solutions

Regulatory Medical Writing for the Pharmaceutical and Biotechnology Industries and Mentoring for Future Medical Writers

Regulatory medical writing

Expertise in producing clear scientific content
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Team training

Guidance for an effective professional team
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Individual Mentoring

Personal development for advanced skills
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Members of EMWA

The European’s Medical Writers Association

Collaborating with Yseop

Scalable automation technology for the pharmaceutical industry

What People Say

Regulatory and creative medical writing services for the Pharmaceutical and Biotechnology Industries and Mentoring for Future Medical Writers

Sarah Tilly was the responsible Medical Writer for the European 2.7.3 and 2.5 MAA modules for a novel treatment for an orphan disease as well as preparing the orphan drug maintenance report.

Sarah rapidly became central to the global team responsible for the European MAA for an enzyme replacement therapy for treating the orphan disease phenylketonuria (PKU) in adults and adolescents. Sarah was very quick and accurate and used her extensive knowledge of registration dossiers to add value in several areas of the submission.

Alan H, Vice President, Head of European Clinical Development, Biotech

We have worked with Azur on templates, and documents. The documents are mainly CSRs, CSR narratives, protocols and ICFs. I always found the quality to be of a high standard and the level of communication high.

It is always a pleasure to work with Azur, Sarah and Adrian always produce high quality documents, within timelines and always with open communication and constant feedback.

Jules K, Head of CRO Medical Writing Department

About Azur Health Science

Our regulatory medical writing company is located in Alsace, France, which allows us to be in direct contact with the latest trends and developments in the field of medicine.

However, our ability to write international content is not limited to our geographical location. We have a diverse team of medical writers who speak several languages and have international experience.

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Our team of medical writing professionals

Experienced collaborators who produce high quality regulatory documents, scientific articles, and medical education materials

Contact

At Azur Health Science, we will take care of all your regulatory and creative writing requirements and train your staff to become the medical writers you need.

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.

We look forward to working with you.

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