Phone: +44 141 899 0081

Our Services

Regulatory Affairs

Paediatric Plans, Scientific Advice, PIM/PRIME/Breakthrough Therapy, Orphan Drug Designation, CTA, MAA, Oral Explanation...

Strategic Development

Regulatory and Development Roadmap, Expedited Pathways, Due Diligence...

Regulatory & Medical Writing

At Kinesys, we excel in communicating science, and provide the expertise you need.

Medical Device

Kinesys can guide you through the regulatory approval process for Medical Devices in Europe and provide advice on compliance with standards.

What our clients say?

"Kinesys have been a great support to us for a wide range of projects, NCEs and Biologics, including Orphans, Scientific Advice, Paediatrics and general regulatory strategy. They have a great, close-knit, highly experienced team that have been together for a long time. Highly recommended."
Kirk Rosemark
Vice President, Regulatory Affairs, BeiGene
"We have worked with Kinesys for over a decade on many regulatory strategy, writing and submission projects. They always deliver high quality work on time and within budget. I particularly like how the team looks out for additional ways to help, for example, helping us locate clinical trial sites for our trials or connecting us with key regulatory agency representatives. I would thoroughly recommend them. "
Adam Rumage
Vice President, Project Management & Regulatory Affairs, Soligenix
"A flexible, knowledgeable and committed team supporting the client in specific scope of what is requested. Kinesys Consulting extended our expertise and provided reliable means to vet and challenge our ideas in a pragmatic way prior to implementation."
Gert De Beckker
Head of Regulatory Affairs, Galapagos