Our core service is regulatory affairs and ,as regulatory experts, we are often asked to explain how international drug registration procedures function and why on earth they need to be so incomprehensible and complicated.
To help our clients we:
· Gain an understanding of their needs and objectives
· Explain what alternative procedures are possible and the associated timeline
· Provide an estimated cost for the alternatives or chosen route
· Implement the agreed plan to achieve the registration
What we have learned over the years is that regulatory projects require diligence and attention to detail to see them through to completion. International regulatory projects do generate significant workload at certain predefined points, often within short time periods, when a fast response is essential to processing a licence application.
This can only be addressed with experienced and well resourced international teams who use state of the art communication tools and techniques to facilitate the management of the projects. To achieve this in 2001 we founded an international network of regulatory experts, regulanet® www.regulanet.com and developed a quality driven system to ensure immediate world-wide communication and flow of information and data.
Since 1994, we have been assisting clients with all types of projects to help them bring their products efficiently to market and thereby maximise value from their asset.We have worked successfully with some of the very largest (and smallest) national and international pharmaceutical companies, and our skilled and flexible workforce allows us to undertake both large and small projects.