Welcome to my homepage!
My name is Dr. Iris Bresink, I am a pharmacist and an experienced medical/regulatory writer with a solid background in the pharmaceutical industry.
I focus on creating clear, accurate, and impactful documents that translate clinical research into drug approval and practical therapies.
More than 25 years of professional experience with expertise in:
Women’s Health
Hematology
Oncology
Men‘s Health
Rare Diseases
Gastroenterology
Immunology
Dermatology
and more …
Services
Regulatory Writing
- Authoring Clinical Overviews and Summaries (CTD Modules 2.5 and 2.7)
- Briefing Books (scientific advice, preNDA/preMAA, End-of-Phase 2)
- Paediatric Investigation Plans (PIPs)
- Response Documents
- Pos-approval documents and safety updates
Clinical Documentation
- Study protocols and reports
- Summaries of clinical efficacy and safety
- Life Cycle Management (Supplementary NDAs, Type 2 Variations)
Submission Strategy Consulting
- Developing regulatory submission strategies for new molecular entities
- Cross-functional collaboration with clinical, regulatory, and statistical teams
- Mentoring medical writers to streamline submission processes
Get in Touch
I will be happy to assist you with any inquiries or ideas you would like to discuss.