AJ Regulatory Affairs & Writing Services
NL-Nederhorst den Berg, N/A 1394 DC
Skills And Services Offered:
Quality, Efficiency, Flexibility and a Personal, Customer-oriented approach are the keywords to my services. I offer writing and editing of:
- Clinical Study Reports
- Manuscripts for submission to peer-reviewed journals (primary papers and review articles)
- Investigator's Brochures
- Investigational Medicinal Product Dossiers for requests for authorisation of clinical trials
- Summary of Product Characteristics
- Patient Information Leaflets
- All parts of Drug Registration Dossiers (Chemical/Pharmaceutical, Non-clinical and Clinical)
- All other scientific documents
Documents can be prepared in English or Dutch. Translation from English to Dutch or vice versa is also possible.
I can easily adapt to any subject and am happy to work in any therapeutic area, but have largest experience in:
- Gynaecology (oral and non-oral contraceptives, postmenopausal hormone therapy
- Andrology (androgens, anabolic steroids, compounds for treatment of prostate cancer)
- Central Nervous System (epilepsy, psychosis, depression)
- Gastrointestinal System (Irritable Bowel disease)
- Herbal medicinal products
After my graduation as a pharmacist in 1988 (State University of Groningen, The Netherlands) I have worked for almost 15 years in regulatory affairs and scientific writing at two large research-based pharmaceutical companies.
In January 2002 I started as a freelance Medical Writer and Regulatory Affairs Specialist, offering services to pharmaceutical companies and contract research organizations. If you would like to have more information on AJ Regulatory Affairs and Medical Writing services and the services offered, please contact me and I will be happy to answer all your questions or send you my information brochure.