Selected Projects & Recent Key Achievements
- We defined and designed non-clinical development programs and early regulatory strategies for more than 100 different products targeting clinical testing in the EU and/or US
- 10 – 15 Scientific Advice / preIND meetings per year are prepared and realized by our team
- In the last 5 years, we achieved authority agreement on numerous non-clinical development programs including CRISPR/Cas9-edited cell therapies (CD34+ cells, CAR T cells and engineered T cells), autologous stem cells, vector-based gene
therapies (including adenoviral, AAV, and novel first-in-class vectors) and viral vector-based vaccines, RNA- and DNA-based therapies and vaccines, a biosimilar, a glycoconjugate vaccine, a herbal preparation, as well as a number of
small molecules
- We also achieved agreement on the biocompatibility testing program of medical devices with EU Notified Bodies and/or FDA, including surface devices, biodegradable implants and drug-device combinations
- We accompanied more than 50 products from early development until first-in-human; 3 from early to MAA; > 20 for MAA/NDA/BLA; 10 to market
- We supported 20 ATMP programs entering clinics
- CAT/CHMP gave a positive opinion on the (Quality and) Non-Clinical Certification Dossier prepared by MC Toxicology Consulting of 3 ATMPs (only a total of 14 ATMPs received a positive opinion by CAT until Nov 2020)
- More than 100 toxicological Risk Assessments were prepared by our team
References to our clients can be provided upon request.