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YASMINE.B

Medical & Regulatory Writer

Regulatory Affairs Consultant — EMA & FDA

rédactrice médicale
Biologiste et spécialiste en marketing, rédactrice médicale, pharmaceutique et bien-être bilingue français-anglais

I am a French Regulatory Affairs Consultant and Medical & Regulatory Writer supporting pharmaceutical companies, CROs and healthcare stakeholders across Europe and international markets.

SERVICES

  • Investigator’s Brochure (IB)

  • Clinical trial protocols (Phases I–III)

  • Clinical Study Reports (CSR – ICH E3)

  • Regulatory documents for ethics committees and authorities (EMA, FDA)

Regulatory & Clinical Writing (EMA & FDA)

1

  • Scientific and medical content for drug development programs

  • Safety & efficacy documentation

  • Medical and regulatory content in English and French

Medical Writing for Pharma & CROs

2

  • Medical SEO content

  • Scientific articles and white papers

  • Educational materials for healthcare professionals

Medical & Scientific Content (Secondary)

2

What Sets Us Apart

All About Me

I am a Regulatory Affairs Consultant and Medical & Regulatory Writer supporting pharmaceutical companies, CROs and healthcare stakeholders in the preparation of clinical and regulatory documentation compliant with EMA and FDA requirements.

With an international background in the pharmaceutical industry and several years of experience in medical and regulatory writing, I work at the intersection of clinical development, regulatory strategy and scientific communication. I support projects from early development stages through later clinical phases, ensuring accuracy, clarity and regulatory alignment.

My work combines scientific rigor, regulatory understanding and strong synthesis skills to deliver high-quality documents for drug development programs, regulatory submissions and health authorities.

Discuss your regulatory or clinical writing needs

Availability for short- and long-term projects

ybenkalfate@gmail.com

+33 6 50 17 66 01

Contact me

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