Pneumology

Indications include

• Cystic fibrosis
• Idiopathic pulmonary fibrosis
• Severe Asthma
• Chronic Obstructive Pulmonary Disease (COPD)
• Pulmonary Arterial Hypertension

Recent assignments

• Perform pre-MAA activities and registration (Centralized Procedure) for a drug to treat Cystic fibrosis
• Act as qualified person (“Responsable Technique”) in Switzerland
• Provide ad-hoc regulatory support for an European CTA
• Prepare and submit a CTA including legal representation and perform a core documents review (Protocol/IMPD)
• Provide pre-market PV services in EU including periodic reporting, product registration/updates in XEVMPD and additional ad-hoc PV support for a drug to treat severe asthma