REGULATORY WRITING

I’m familiar with ICH, EMA, and FDA guidelines – and have the skillset to help life science companies navigate the regulatory landscape with clarity, strategic insights, and precision.

Over the years, I have developed proficiency in regulatory frameworks, submission dossiers, and technical writing best practices.

Key Expertise:
✔Regulatory Documents – Clinical Study Protocols (CSP), Investigator’s Brochures (IB), Clinical Study Report (CSR)

✔Regulatory Frameworks – ICH E3, ICH M4, ICHE6, FDA, EMA, GxP Compliance, QC Review

✔Data Interpretation – Summarizing clinical trial results, statistical data, and safety reports

✔Cross-Functional Collaboration – Working with clinical, regulatory, biostatistics, and safety teams to align content with submission requirements.

By developing high-quality regulatory documents and ensuring compliance with evolving regulatory guidelines, I streamline and facilitate regulatory submission processes. 

Are you a company in biotech, pharma, CRO, or medical device looking for an expert regulatory writer to support your regulatory submissions? Let’s connect.