Dr Dima Al-Hadithi BPharm, MRPharmS, GPhC, MTOPRA

RareGenix Partner, CMC Lead

Dr. Dima Al-Hadithi brings over 20 years of expertise in the development and licensing of medicinal products and drug-device combinations across multiple therapeutic areas, including rare diseases. She specializes in CMC strategy, guiding companies through product development and regulatory submissions to accelerate approval and enable life changing therapies to reach patients.

As a former Senior Pharmaceutical Assessor at the MHRA, Dima provided scientific advice to developers and assessed UK/EU marketing authorisations.

Dima has led CMC development for advanced therapies, including an Ad5-based therapy for head and neck cancer, and contributed to multiple programs in early and late-stage development. Her expertise spans CDMO selection, product development, analytical strategy, GMP compliance, and regulatory planning. She has hands-on experience with US-FDA, EMA, MHRA, and other regulatory authorities.

As an active regulatory professional, Dima stays at the forefront of evolving regulations, ensuring her clients navigate complex regulatory landscapes efficiently.

Partner with Dima to bring your innovation from development to regulatory approval with confidence.

Advancement of Life-Changing Therapeutic Medicines for Rare Disease

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