Confidence Beyond Compliance
Since the introduction of the Tissue and the Advanced Therapy Medicinal Products (ATMP) regulatory framework in the EU and the corresponding Cell and Gene Therapy framework in the US, we support clients in navigating through this highly challenging environment.
Due to the rapidly evolving ATMP landscape it’s key to have up-to-date knowledge and expertise to successfully develop a product and gain a centralized market authorization (MA) in Europe and / or a Biologic License Authorization
(BLA) in the US. ATMP development requires experts and specific experience in regulatory strategy, CMC and clinical development a unique management of various aspects throughout the overall development pathway.
- Full regulatory support for development, authorization and lifecycle management
- Consulting on appropriate development strategies (e.g. biodistribution, tumorigenicity, orphan designation)
- Support for specific procedures like classifications, certifications, Orphan designations, SME application, GMO application etc.
- Preparing and participating at ITF, SA at EMA or national authorities and FDA
- Facilitating the communication with scientific committees of EMA (e.g. CAT, PDCO, COMP) and FDA (e.g. advisory Board meetings)
- Writing of documents for clinical trials in EU or US (i.e. IMPD, IND, IB)
- Development of PRIME, hospital exemption, compassionate use for patients and early access programs
- Developing and writing of paediatric investigation plan
- Writing or review of all CTD documents for MA applications