Advanced Therapies

Regulatory bodies give special attention to Advanced Therapies, such as gene therapy, somatic cell therapy and tissue engineered products. The aim is to address recent innovation in this field which has led to the emergence of novel therapeutic and diagnostic approaches to health issues. Such innovative projects are often driven by university-associated institutions and small companies dedicated to research. Special regulations address the needs of such organisations by e.g. enabling early interaction with the regulators through cost-free Scientific Advice meetings in Europe or “pre preIND” meetings in the US. In the EU it is also possible to ask for a regulatory review of the manufacturing and nonclinical data in early stages of product development and in advance of an MAA submission (Quality and Nonclinical Certification of ATMPs).

At Granzer Regulatory Consulting & Services we have experience with over 15 different Advanced Therapy projects in all stages of development, be it in the phase of transition from research to development, the initiation of phase I clinical trials, preparation of dossiers for Marketing Approval or BLA or the support during the phase of authority review for licensing approval. We’d be happy to share our unique experience with you.

• Regulatory Strategy
• Regulatory Procedures
• Advanced Therapies
• Orphan Drug Development
• Paediatric Development
• Medical Devices
• Borderline Products
• Authority Meetings
• Electronic Submissions
• Market Access & Value Dossier
• Small & Medium Enterprises
• Medical Writing
• Project Management
• Due Diligence

• Business Development