For Manufacturers of Medical Products

The purpose of medical writing is to create documents that effectively and clearly express the messages scientific data have to tell. Additionally, the documents must comply with regulatory, journal or other national and international guidelines in terms of content, format and structure. Examples of medical documents include clinical study protocols, patient informed consent forms, leaflets, investigator brochures, and summary documents of all the combined data gathered in the course of developing a drug or medical device.

The utility of medical writing

Medical writing plays an eminent role in preparing various documents for companies, varying from development phase up to product introduction and marketing. Due to proper medical writing, large amounts of clinical data and scientific information are communicated clearly and in compliance with European and national directives to a scientifically sophisticated audience. A correct, medical written document encompasses the appropriate and relevant information; the message is clearly addressed; the style is adjusted to the type of audience and the entire document is comprehensive and navigable.

Medical writing in pharmaceutical companies is fundamental in for instance preparing documents for regulatory submission as a part of applications for marketing authorizations. These are highly technical dossiers aimed at a multidisciplinary audience. Proper medical writing will speed up the process of approval and subsequently market introduction.

Finally, competent medical writing can be used as a powerful marketing & sales tool as scientific and medical communication, in the form of product presentations and brochures. Thus as an effective method of promoting your products.

We can support you in:

Writing and compilation of any of your regulatory or scientific medical documentation in a wide variety of formats. The targeted document can range between short stand-alone pieces to the compilation of large files for product approval.

We integrate the document essential information and present the data in a navigable, organized format. Before being handed over to the client, the drafted document shall be reviewed by the senior managers of BioTop Medical to ensure high quality (precision and consistency), transparency and that the document goal was accomplished.