NDA Services

NDA provides integrated advice and support to help you remove the hurdles to reach the market.

NDA provides advice and support to provide you with up to date intelligence on local and central European regulatory requirements throughout the product life cycle. The aim is to integrate the external requirements into development as early as possible to ensure approvable and reimbursable outcomes.

NDA’s expertise spans strategic services such as:

• Input into development plans
• Advice on appropriate end-points with market authorisation in mind
• Advice on clinical trial partner selection, due diligence and strategy
• Considerations for the applicability and use of products in children
• Patient safety strategy through risk management, policies and procedures
• Quality process design and advice on manufacturing considerations
• Scientific advice for pharmaceuticals, biopharmaceuticals and advanced therapies

To ensure compliance through the development, approval and marketing phases NDA provides competent support services such as:

• Clinical trial applications
• Orphan drug designations
• Paediatric Investigation Plans
• Risk management and incident report management
• Centralised and decentralised procedures
• Electronic submission publishing and life cycle management
• Validation of facilities, utilities, processes, methods and test equipment
• Periodic safety update reports
• Patient information production and management
• Preparation for regulatory inspections
• License variations
• New indications
• Qualified person