Selected Projects & Recent Key Achievements
- We prepare and realize 10 – 15 Scientific Advice / preIND meetings per year
- In 2016 we achieved authority agreement on the non-clinical development program of CRISPR/Cas-edited cells, autologous stem cells, vector-based gene therapies, a biosimilar, a glycoconjugate vaccine and an RNA-based vaccine, a herbal preparation, small molecules, and RNA- as well as DNA-based oligonucleotides.
- We also discussed and achieved agreement on the biocompatibility testing program of medical devices with notified bodies
- We define and design non-clinical development programs and early regulatory strategies for more than 15 different products per year targeting the clinical program in the EU and/or US
- In the last few years we accompanied more than 30 products from early development until first-in-human or and some even until MAA
- Until end of 2016 CAT/CHMP gave a positive opinion on the (Quality and) Non-Clinical Certification Dossier prepared by MC Toxicology of 3 ATMPs (only a total of 10 ATMPS received a positive opinion by CAT)
- We prepare more than 20 PDE calculations per year, a similar range for impurity assessments
- We author 5-10 non-clinical sections of a CTD every year
References to our clients can be provided upon request.