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.
Team Medical Writing
Our key areas
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)