Regulatory services
“We understand the tremendous pressure faced by today’s Regulatory Affairs teams: dynamic commercial demands, competing priorities, ever-changing requirements from health authorities, dwindling pipelines and rising pressure on pricing to name a few. Through our fully integrated, end-to-end capabilities, we help clients move to more flexible outsourcing approaches to meet their license maintenance, Regulatory Strategy and Pharmacovigilance activities.”
Stuart Donald, Global Head of Kinapse and Board Director
Our Regulatory services
Our Pharmaceutical Regulatory consulting and operations team are experts in regulatory requirements. Working on a global scale, we help the majority of the world’s Pharmaceutical companies stay one step ahead of regulatory changes, and optimize their end-to-end regulatory activities.
Regulatory Strategy
Our Regulatory Strategy team work with your in-house team to develop comprehensive regulatory strategies, which allow your organisation to successfully commercialize your products, unhindered by regulatory slow-downs.
Regulatory Maintenance
We have an unmatched global Regulatory Maintenance and operations capability to deliver exclusive end-to-end solutions for the life cycle maintenance of your product portfolio.
Discover how our services can help you
The regulatory burden on pharmaceutical companies is growing continuously. Your clinical, regulatory and pharmacovigilance teams have to work harder than ever to stay on top of requirements and execute more and more routine activities.
Outsourcing your clinical trial transparency and post-approval regulatory/pharmacovigilance support to Kinapse gives you confidence that you will remain compliant in these areas and frees up your teams to focus on more strategic activities.
