Medicines

Preparation and submission of New Marketing Authorization applications (Swissmedic)

• Advice on submission strategies
• Literature research and creation of literature-based dossiers
• Preparation of company meetings (Scientific Advice, Presubmission, Clarification)
• Co-Marketing Applications

Life Cycle Management

• Preparation and submission of variations (Quality, Product Information)

Due Diligence 

• Assessment of the completeness and up-to-dateness of the product dossier
• Status of ongoing procedures and variations

Other product categories

Medical Devices, Cosmetics, Food Supplements

• Market access and advice on differentiation criteria for product categories