Ophthalmology and ENT Stomatology

Indications include

• Age-related Macular Degeneration
• Corneal graft rejection
• Diabetic Macular Edema (DME)
• Leber Hereditary Optic Neuropathy
• Neovascular glaucoma

Recent assignments

• Prepare and submit an EU ODD annual report and review the sponsorship transfer dossier
• Provide CMC Support on a gene therapy product
• Perform a critical analysis of toxicology reports and prepare recommendations
• Prepare and submit as EU Legal Representative a CTA in 5 EU countries (incl. development of IB & IMPD)
• Provide pre-market PV services for a clinical trial in France with a gene therapy product
• Advice on clinical development plan and market access strategy