Dr. Petra A. Schwantes
Your experienced expert for medical writing – working both individually and, of course, as integral part of your team – your reliable partner at any stage of the drug/medical device development process: from non-/clinical research, to regulatory approval documentation, and up to scientific communications for professionals – in both English or German depending on your needs.
Manuscripts for medical and scientific journals: research papers, review articles, abstracts
CTD Nonclinical Modules (2.4, 2.6)
CTD Clinical Modules (2.5, 2.7)
Clinical Study Reports
Medical devices (substance-based)
Clinical evaluation reportsMedical writing of other documents required for the Technical DocumentationAssistance and tailor-made advice in assembling the Technical Documentation
Assistance in preparing your scientific communications to meet the needs of any peer-reviewed medical or scientific journalReview and evaluation of existing data and regulatory documents in your non-/clinical CTD submission dossiers to increase efficiency in the approval process
Competent analysis and interpretation of your data, no matter their complexity
Always an eye for the wider scientific context
Clear, concise and consistent scientific writing
Communicating results of your clinical research to the professionals
. and regulatory authorities in a highly comprehensive manner
In-depth discussion and interpretation of your nonclinical and clinical data
Highly advanced English skills with a particularly deep field-specific knowledge
Professional freelance medical writer with extensive experience in
. writing of peer-reviewed articles for international medical and scientific journals
. preparation of nonclinical and clinical documents used in more than 50 CTD submissions in over 30 countries
Particular expertise in pharmacology, toxicology, urology, dermatology, and gastroenterology
Scientific background: German Diplom degree in Biology and doctorate (PhD) in Natural Sciences
Mode of Operation
Closely working together with you to solve your ambitious projects
Outsourcing with easy accessibility at your convenience
Strict confidentiality regarding all data and information of your project
Independent literature research and integration into your documents and data
Preparation of regulatory documents in accordance with all legal requirements and relevant guidelines of the European Medicines Agency ( EMA)
Preparation of Technical Documentation sections in accordance with all legal requirements and relevant guidelines of the EU Regulation 2017/745 on Medical Devices (MDR), and the European Commission Guidelines on Medical Devices (MEEDEV) 2.7/1 rev. 4
Writing of peer-reviewed articles in full compliance with the rigorous standards of:International Committee of Medical Journal Editors (ICMJE)
Good Publication Practice 3 guidelines (GPP3)
CONsolidated Standards Of Reporting Trials (CONSORT)
Strengthening the Reporting of OBservational studies in Epidemiology (STROBE)
Prevention and Recovery Information System for Monitoring and Analysis (PRISMA-Medical method)
Statistical Analyses and Methods in the Published Literature (SAMPL guidelines)Compliance with any special journal requirements
Memberships:European Medical Writers Association ( EMWA)
Deutsche Gesellschaft für Pharmazeutische Medizin e.V. ( DGPharMed)
Forum Med Tech Pharma e.V.
My values – your benefits:
Advantages & Commitment
For you, outsourcing means simplification and streamlining of processes.
For me, outsourcing means full dedication to your project with a focus on suitable solutions.
Reliability & Competence
I put great effort into my work and take pride in my strict adherence to timelines and feedback from clients that I provide high-quality medical and scientific texts, both for regulatory purposes or for publication.
Flexibility & Teamwork
Scientific challenges come from various directions. In this light, I will work closely together with you by providing responsive services of very high standards, perfectly tailored to meet your needs.
Whatever your challenge:
it is my goal to help you turn your complex information into a meaningful, concise and reviewer-friendly document.
I’m looking forward to hearing from you!