Your individual support for Medical Writing

Accurate – Innovative – Quality conscious

We communicate science. What is your superpower?

Our Medical Writing team is your point of contact for all kinds of medical and scientific questions. Regardlesss which medical texts you need: We know the legal framework, the subject-specific requirements, and the requirements of the target group.

How we work
  • We talk
  • We look
  • We listen

High quality meets pioneer spirit

We handle your routine projects with the greatest professional care, and are also happy to develop new progression opportunities for your products.

Individual problem solutions

Are you facing special challenges? We listen and deliver tailored strategies based on years of know-how and creativity.

Interlaced thinking & working

We see ourselves as an interface between Research & Development, Regulatory Affairs, Marketing & Sales and Pharmacovigilance.

Our key areas

  • Content for CTD (Common Technical Document)
  • Text updates + medical check
  • Post-requests by the authorities
  • Toxicological reports
  • Expert statements
  • Accessible patient information leaflet
  • OTC switch

Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) are also a focus of pharmacovigilance.

On request, our Aggregate Reports support includes:

  • Preparation and updating of RMPs
  • PSUR/PBRERs: creation, submission and tracking
  • Risk minimisation measures
  • Addendum clinical overview (ACOs)
  • Clinical expert statement
  • Developmental safety update report (DSUR)
  • Study Protocol
  • Investigator’s Brochure
  • Investigational Medicinal Product Dossiers (IMPD)
  • Clinical Study Report
  • Development safety update report (DSUR)
  • FSMP Dossier
  • Delimitation issues
  • Support for official communication
  • Biological- /Clinical Evaluation Report
  • Scientific Storytelling
  • Training and information materials
  • Congress support
  • Publications

Regulatory Affairs (RA)-Writing:

Authorisation procedures require professional expertise and the ability to implement them accordingly. We support you throughout the entire life cycle of your products:

  • Content for CTD (Common Technical Document), update or new creation of Non-Clinical and Clinical Overviews and Summaries
  • Updates of texts (technical information, instructions for use) including medical checks
  • Regulatory requirements (RSI, PRAC requests, Safety Assessments)
  • Addendum to the Clinical Overview (ACO) in the course of renewals
  • Toxicological reports
  • Accessible patient information leaflet
  • Expert Statements (e.g. for Scientific Advice Meetings)

Pharmacovigilance requires medical expertise as well as knowledge of Good Pharmacovigilance Practices (GVP). Contact us if you need our expertise for your Risk Management Plan (RMP) and Periodic Safety Update Reports (PSURs). We also support you with the implementation of training materials, from translation to regulatory approval to distribution.

Are you looking for medical writing support during the clinical development phase? We support you with:

Do you need exciting medical stories for your professional and non-professional communication? Should proven indications or active ingredients be recounted? We search for the corresponding literature or bring new aspects from the existing literature and offer you:

  • Publications, including submission to the selected journal
  • Information material for professionals, e. g. brochures, manuals, posters, checklists, fast facts, slides
  • Training materials for doctors, pharmacists, employees
  • Medical storytelling, e. g. script for explanatory videos

Do you need an overview of the state-of-the-art therapy of an indication? The latest publications on an active substance or a group of active substances? A research on basic scientific questions? We are happy to provide you with our know-how and deliver the desired output.