Cell, Gene and Tissue Therapy

Significant experience in the development and registration of somatic cell therapies, gene therapies and tissue engineered products (ATmPs in Europe)
Design and implementation of risk-based development plans
Interactions with regulatory agencies and experts
Specific expertise in development of stem cell products

Clarification on regulatory status and guidance on optimal registration pathway
Risk-Analysis
Nonclinical development (proof of concept, biodistribution, tumorigenicity etc.)
CMC assessments including viral safety, potency assays and comparability issues expertise
Nonclinical and CMC EMA certification
Clinical Trial Applications (CTAs, INDs, etc.)
Meetings with regulatory agencies at all stages of development with focus on early stages (pre-IND, End of Phase 2, Innovation Task Force Meetings, national and EMA Scientific Advice)
Marketing authorization (MAAs, BLAs)