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DOSSIER-WRITING-AS-A-SERVICE

A dossier is like a book.
THE FORCE ensures that people enjoy reading your application.

Why is good dossier writing important?

An approval dossier for a medicinal product or the technical documentation for a medical device follows complex rules and guidelines. In order to make the approval process smooth, it is essential to be well-versed in the regulations: too much or too little detail is equally critical, and completeness of the dossier is crucial. If the documentation is not only complete but also well written, then this is an important milestone on the way to the goal: the successful market launch.

We navigate the various regulations with confidence. You too can benefit from our team's experience with a variety products.

Where can we support you with our dossier writing service?

When preparing a marketing authorization dossier for medicinal products:

Whether Module 3, clinical opinion, or product information texts – we have the expertise to provide all parts of a marketing authorization dossier. Above all, we’re pleased when we get to prepare and submit complete dossiers and can accompany the product through the procedure.

When it comes to variations:

From complex quality changes to updates in your product information texts, we create a data package for submission from a single source – prepared in an easy and comprehensible way so that the authority can readily understand it. For more information about this, see our Lifecycle-As-A-Service.

When necessary for pharmacovigilance:

Both risk management plans and educational material are part of our portfolio.

When looking for support for an Environmental Risk Assessment (ERA)...

...that’s required for all new marketing authorization applications for medicinal products.

Contact us

to ensure people enjoy reading your application.

DOSSIER-WRITING-AS-A-SERVICE

Why is good dossier writing important?

Where can we support you with our dossier writing service?

When preparing a marketing authorization dossier for medicinal products:

When it comes to variations:

Contact us

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Smells like team spirit.

Boldly go where you've never gone before.

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Trust is a choice.

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Strength lies in differences, not in similarities.

Every person is our strength.