Neurology, CNS & Addiction

Indications include

• Parkinson disease
• Alzheimer disease and other dementia
• Stroke
• Epilepsy
• Depression and psychiatric disorders
• Pain all types including Migraine
• Duchenne muscular dystrophy and other myopathies
• Charcot Marie-tooth disease
• Progressive supranuclear palsy
• Addictions (Cannabis, Alcohol, etc.)

Recent assignments

• Prepare and submit MRP application and provide regulatory support towards the local/national requirements across
• France, Germany and 6 other European states
• Provide CMC, clinical and nonclinical ad-hoc assistance for a small molecule indicated in neuropathic pain
• Manufacturing and preclinical strategy for beginning a Phase I trial
• Prepare & submit clinical trial applications in various EU Member States for a Phase III trial in Alzheimer’s Disease
• Pharmacovigilance support for a MAA application, including post-market PV support
• Assistance with SEED early dialogue with HTA bodies