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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."
"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. "
"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."
"Kinesys has provided excellent technical, regulatory and strategic support for a number of projects at the UCL Technology Fund. The team’s expertise, as well as their flexible and client-oriented approach, was incredibly useful during the development of our commercial plans and we would highly recommend them."