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.