Drug Development and Regulation
We have extensive experience with regulatory strategies and procedures in Europe both at the EMA and national regulatory agencies.
The DDR team and its Network of experts successfully conduct regulatory applications (Orphans, Scientific Advice, CTA/IND, PIP/iPSP, SME designations and MAA/NDA) and Expedited Regulatory Pathways (PRIME, BTD).
DDR has also regulatory expertise to support Medical Devices and In-vitro Diagnostics in Europe and to adapt all of them to the new Regulations.