Compliance Solutions cover regulatory and compliance matters in the Pharmaceutical, Biological and Medical Device industries, from small start-up companies through to large multinationals. We have led product development programmes from concept through to market, successfully registered products across a range of disciplines, and implemented relevant quality management systems necessary to market those products.
We have obtained over 100 CE marks for companies – ranging from simple devices such as wound dressings, to class 3 implants; spinal, vascular peripheral and access grafts, heart valves, sphincters and stents.
We advise on the design, planning and monitoring of clinical trials to meet regulatory requirements as part of the product development programme, and deliver expert guidance on how to best meet the regulatory requirements of the MHRA, FDA, Health Canada, Notified Bodies and ICH.
Compliance Solutions are helping SMEs along the way in making sure that their product and the manufacturing processes used to manufacture these products are compatible with their use in the healthcare / medical sector.
View a snapshot of some recent clients served and products delivered, below.