DE | ENG

BioMedical Services | Dr. Petra A. Schwantes


Medical

 

Writing


Precise. Analytical. Scientific.

image Dr. Petra A. Schwantes, Medical Writerin
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 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.
  • Stacks Image 11094
  • Stacks Image 11096
  • Stacks Image 11098
 

Services

  • Scientific communications
    Manuscripts for medical and scientific journals: research papers, review articles, abstracts
  • Medicinal products
    CTD Nonclinical Modules (2.4, 2.6)
    CTD Clinical Modules (2.5, 2.7)
    Clinical Study Reports
    Investigator Brochures
  • Medical Devices
    Clinical evaluation:
    European Medical Device Regulation (MDR) 2017/745, Article 61
    European Commission Guideline on Medical Devices (MEDDEV) 2.7/1 rev. 4
  • Support
    Assistance in preparing your scientific communications to meet the needs of any peer-reviewed medical or scientific journal
    Review and evaluation of existing data and regulatory documents in your non-/clinical CTD submission dossiers to increase efficiency in the approval process

Precise.


Analytical.


Scientific.

  • Stacks Image 11146
  • Stacks Image 11148
  • Stacks Image 11150
 

Profile

  • Expertise
    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
  • Experience
    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
  • Standards
    Preparation of regulatory documents in accordance with all legal requirements and relevant guidelines of the European Medicines Agency ( EMA)
    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.
  • Stacks Image 11204
  • Stacks Image 11206
  • Stacks Image 11208
 


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!