Services

Regulatory Affairs Services

Support is provided for projects throughout the product development cycle from inception through to Marketing Authorisation application (MAA) and post-marketing

Development

• Product development strategy
• Regulatory intelligence
• Scientific advice and Pre-submission meetings
• Agency liaison
• Company formation
• SME declaration
• Orphan drug designation
• Clinical trial approval (CTA) (IND)
• Patient/User leaflet testing
• Gap analysis
• CTD preparation
• Submission management

Post-marketing

• Interim management/contract staff
• Line extension
• MA variations
• Advertising materials compliance