Kinesys provides Strategic & Operational Regulatory Affairs Services. This extends to Strategic Planning & Writing for all types of Applications: – Scientific Advice, – Orphans, – CTA/IND, – PIPs/iPSP, – Early Access/Expedited Pathways (PRIME, BT, PIM etc.) – & MAA. We are experts in Hemato-oncology, Neurology & Rare Diseases and our experience covers NCEs, biologics, ATMPs & devices. We have a unique platform, EMA Solutions, of ex-EMA & other EU Agency experts to support clients at critical timepoints.