Services We Provide

Regulatory benefits provides you with tailor-made support in a wide range of drug development, licensing and reimbursement activities.

tai•lor–made adjective\ ’tā-lər-‚mād\

Made or designed especially to suit a particular use or purpose

• Advice on overall regulatory strategy for all types of medicinal products
• Guidance on the general regulatory framework – from early clinical development to licensing phase and life-cycle management
• Hands-on support with the preparation and compilation of regulatory submissions
• Regulatory input for your partnering and due diligence activities
• Ad hoc support with day-to-day operational issues
• Reliable, competent and flexible support

Areas of expertise:

• Navigation and consideration of applicable laws and regulations in all phases of drug development and licensing
• Regulatory strategy for clinical development plans
• International clinical trial authorizations (CTA), US Investigational New Drug (IND) applications
• Marketing authorization applications (including project coordination, responses to agency questions, preparations for oral explainations etc.)
• Orphan drug designation applications
• Specialised regulatory procedures (e.g. fast track, breakthrough therapy designations, accelerated assessment, etc.)
• Registration as micro, small or medium-sized enterprise (SME)
• Paediatric regulations and requirements (PIP, waiver requests etc.)
• Interactions with international regulatory agencies (including scientific advice,protocol assistance, pre-submission meetings etc.)
• Overview of pricing and reimbursement procedures in key European markets