About us

As the founder, Marie-Line El Helou, PharmD, brings extensive experience in pharmacovigilance, regulatory compliance, and scientific communication, gained through working with organizations across the pharmaceutical and biotechnology sectors.

Throughout her career, she has supported products at every stage of their lifecycle—from clinical development and early access programs to marketed medicinal products—ensuring compliance with French and European regulatory requirements.

She established ML PV & Medical Writing Consulting with a clear objective: to provide high-quality, personalized pharmacovigilance expertise that helps clients navigate complex PV requirements, optimize operational efficiency, and enhance product safety performance.

To offer comprehensive and flexible support, Marie-Line collaborates with a trusted network of experienced freelance professionals whose complementary expertise spans pharmacovigilance, regulatory affairs, medical writing, public health, and related life sciences disciplines.