Services
I provide expert medical and regulatory writing services to create high-quality documents for drug approval. With extensive experience in clinical development and regulatory processes, I provide tailored support to guide clients from early-stage strategy through post-approval requirements.
My services include authoring a wide range of clinical documents – ensuring accuracy, clarity, and full compliance with regulatory standards. Additionally, I offer consulting on regulatory strategies and documentation workflows to optimize submissions and streamline the approval process.
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.