Kinesys Consulting provides Strategic Development, Regulatory Affairs, Medical & Regulatory Writing, and Medical Device support and services to a highly varied portfolio of clients within UK, Europe and USA, as well as in emerging and other markets.
Since 2007, we have been known as a high-quality service provider whose senior consultants have a wealth of experience and expertise across most biopharmaceutical product classes, therapeutic areas and regulatory applications. We regularly represent clients at EMA, EU NCAs, and US FDA for different types of projects and Applications, including at key regulatory meetings. In the Regulatory field, our services extend to MAAs, CTA / IND, Orphan Drugs, Scientific Advice, Paediatric Investigational Plans and other strategic and technical support. Our Writing services include all types of Clinical documents (protocols, IB's, summaries, etc), manuscripts and abstracts, and relevant sections of Regulatory Applications. The Medical Devices function supports clients with audits, CE / UKCA marking, device regulatory consultancy including drug-device combinations, and acting as the Responsible Person.
The company benefits from a top class Advisory Board whose members are available to help resolve our clients’ regulatory, clinical, nonclinical and CMC challenges.