Darine Diab

Holder of a PhD in Pharmacology, I have 10 years of experience in R&D, in both the public and private sectors. Today, I work as an independent consultant, putting my expertise at the service of companies - from startups to large groups - to optimize the market launch of their health products through rigorous regulatory compliance.

I support my clients in all stages, from product design to obtaining CE marking or marketing authorization. My approach is strategic, personalized, and human-centered, with comprehensive technical and regulatory support to develop the best development and commercialization strategy.

In collaboration with companies, I take charge of drafting, submitting to authorities, and monitoring registration files, in compliance with regulatory and normative requirements.

• Inflammation / Immunology

• Oncology

• Infectious diseases

• Medical devices

o Scientific/technological state of the art assessment;

o Drafting of scientific & technical documents (study reports, articles, responses to health authorities, review of registration files, etc.);

o Scientific support for drafting the Clinical Evaluation Report (CER);

o Preparation of technical files for CE marking of medical devices;

o Drafting and updating of risk management & usability engineering files;

o Research and identification of new products, targets, processes, or innovation avenues;

o Project management and strategic monitoring;

o Review and drafting of MA files, IMPDs, and investigator brochures (IB) Strategic evaluation of R&D projects;

o Scientific and regulatory watch.

If you would like to know more or discuss a collaboration, do not hesitate to contact me!