Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics.

Perfect for our partners who want deeper insights into specific domains of their choice. With our Online Customer Panel survey, we have a fast and effective way to gather quantitative insights. Also we are organizing Life focus groups, which you can experience the immediate, unfiltered voice of the patient in a live environment. Gather insights and generate new ideas based on direct feedback from customers.

Medical communications are documents about drugs, devices and biologics written for general or specific audiences such as health care professionals.

Train your medical writers by Emtex professionals. Educate to Elevate.

Services

Services and solutions offering

We provide a wide range of medical writing & related services and offer solutions tailored to your specific needs.

Writing documents and presenting data in a clear and well-structured manner is Emtex’ core competence. Our skilled team members are flexible and proactive and take ownership of your needs from beginning to end to guarantee success.

Our medical writing and related services are grouped into 4 domains. An overview of the most common services within each domain is provided below. We can offer more services and solutions besides those listed below. Contact us to learn more about our services and how we can meet the specific requirements and needs of your company.

How can we help you?

Over the years, we have gained extensive experience in the presentation and interpretation of data into well-structured, clear scientific documents. Emtex has contributed to several successful submission dossiers. We can support your company in the preparation of the documentation needed to speed up the development processes on the way to regulatory submission and approval. An overview of the most common regulatory medical writing services is provided here.

We offer research & insights services for customers who want to dive deeper into specific domains of their choice or who want to get a better understanding of their data through statistics, graphics or dashboards.

Data collection can occur via our Online Panel Survey or Life Focus Groups, which allows to gather further insights and generate new ideas based on direct feedback.

Data can be analyzed and transformed into graphics or dashboards to aid in the interpretation and communication. Statistical expertise & support is available to ensure the best possible results.

Statistical Consultancy

The Emtex biostatistician can be consulted for study-specific tasks (such as study setup, a DMC, or additional analyses) or for more overarching tasks (such as clinical development plans or briefing packages).

We can provide media & communications services fitted to your audience (general or professional) in the desired format such as written, audiovisual, oral or online materials and many others. An overview of the most common media & communication services:

Our professionals have developed several training sessions for medical writers. We can also offer tailored courses for medical writers adapted to your specific training needs. It can take place in our facilities, your company, other location, or even online. Our trainers are professionals with sufficient experience in the field.

Customer testimonial:

“I can really trust the Emtex writers to deliver a quality document on time, to reach out to me or team members when appropriate, and to adapt to our changes in process/template over time. The consistent quality of work– and that this is true of all the writers. The willingness and ability to learn and improve. The good balance between independent work and reaching out to me or the team when appropriate. The effective and friendly communication.”

Senior Medical Writing Leader

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