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SCIENTIFIC-WRITING-AS-A-SERVICE

When things get complicated, the experts at THE FORCE come into play and prepare your data in a clear and understandable way.
We ensure that the information is optimally presented and understood by the recipient.

The market launch of a drug, medical device or food supplement is complex: many studies have to be carried out and data collected to prove that a product is effective, safe and of high quality. We know how to prepare the data in an understandable manner and present it in the best possible way.

For the development phase:

We prepare the scientific consultation with authorities or notified bodies and create briefing books and presentations for these discussions. Acting in a position of a “test authority” we rigorously evaluate the documents for plausibility. We are confident to accompany you to these meetings and “fight” alongside you for a successful outcome.

For the marketing authorization dossier for medicinal products:

Our experienced team prepares expert reports on quality, preclinical or clinical studies (modules 2.3, 2.4, 2.5) as well as on the associated summaries (modules 2.6 and 2.7) for the submission of your marketing authorization application. We handle applications based on our own studies just as confidently as literature-based or hybrid applications.

For the certification of medical devices:

We prepare the clinical evaluation to prove safety and performance. This evidence can be provided on the basis of literature data or our own studies and is an essential part of the technical documentation. The clinical evaluation must be kept up to date even after marketing has begun.

In the life cycle of your product:

On various occasions during the life cycle of your product, complicated relationships are described, e.g. changes in the manufacturing process, in the product information or the evaluation of new impurities. A clear, scientifically sound and well-formulated presentation makes the assessors' work easier and helps you to achieve your objectives more easily.

For risk assessments:

Risk assessments in accordance with ICH Q3D or on the occurrence of nitrosamine contamination are now standard and are requested on various occasions. We obtain an overview, gather all the necessary information and cast the risk assessment in a presentable format, accepted by the Authorities. We work on an interdisciplinary basis and benefit from the expertise of our toxicologists.

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for clear and understandable data in your scientific writing.

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