Regulatory Writing


Study Protocols (all Phases incl. NIS/ Observational Studies)


Study Reports according ICH E3 (CORE Reference) or ISO 14155:2020


Clinical Evaluation: Clinical Evaluation Plans, and - Reports, and related documents


Documents for Patients, Questionnaires and Informed Consent Forms


Case Report and/ or Observation Forms


Study-related translations (GER/EN)


more services upon request ..

Scientific Writing


Publications (Peer- reviewed),


Literature Searches and Reviews


Congress Presentations and -Posters


Manuscript Reviews







more services upon request ..


Prices and Project Plan


Prices are calculated according to the effort and extent of each project and the required services within the project. They will be presented transparently and comprehensively in a cost offer. Prices follow the customary rates for Freelance Medical and Scientific Writers of the European Medical Writers Association (EMWA). The chosen document language (EN/GER) doesn’t have an impact on pricing. Please understand that I won’t give any standard prices here, projects can be too diverse in order to name a “universal rate”.


After receipt/ agreement of your project, the required hours and services will be calculated and will be summed up in a cost offer. Depending on the project, now the writing, the research or the composition of graphics/ tables can begin.


When the first draft is finished, you, and possibly co-authors of other involved parties, can document proposed amendments that I will then implement into the final version. Two review cycles are included by default in the project plan. The first review cycle concerns content and structure of the documents. The second cycle includes a mandatory quality check (document-adjusted check lists; or upon request by another involved person).


Depending on the contracted document/s, you will receive a full publication for submission to German or international journals, a congress presentation or poster, or finished study documents, e.g. study report.